FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKIN SCRUB TRAY STERILE SKIN SCRUB KIT
K Number: K842490
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
20
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SKIN SCRUB TRAY STERILE SKIN SCRUB KIT
- K Number
- K842490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Biological & Environmental Control Laboratories
- Date Received
- June 26, 1984
- Decision Date
- August 17, 1984
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRG), ordered by most recent decision date.
Dukal Crepe Paper Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
Sterilization Pouch/Roll
FDA 510(k)
FDA Class 2
·General Hospital
Self-Seal Sterilization Pouch and Roll
FDA 510(k)
FDA Class 2
·General Hospital
Chex-All Sterilization Pouches and Tubes
FDA 510(k)
FDA Class 2
·General Hospital
Sterilization Pouch and Roll
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Biological & Environmental Control Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K971500 | ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER | Aug 18, 1997 | Substantially Equivalent |
| K962802 | SAFE MATE I.V. FLUID DELIVERY SETS | Aug 28, 1996 | Substantially Equivalent |
| K962801 | SAFE MATE I.V. EXTENSION SETS | Aug 28, 1996 | Substantially Equivalent |
| K961328 | BEC SHROUDED PLASTIC CANNULA | May 30, 1996 | Substantially Equivalent |
| K961327 | BEC NEEDLELESS INJECTION SITE | May 15, 1996 | Substantially Equivalent |
| K863635 | UPDATED STERILE ENDOTRACHEAL BRUSHES | Nov 3, 1986 | Substantially Equivalent |
| K863633 | SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES | Oct 16, 1986 | Substantially Equivalent |
| K863636 | UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS | Oct 6, 1986 | Substantially Equivalent |
| K863632 | UPDATED STERILE PROCEDURAL KIT | Sep 29, 1986 | Substantially Equivalent |
| K863637 | UPDATED STERILE GOWNS, MASKS AND TOWELS | Sep 29, 1986 | Substantially Equivalent |