FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOSPITAL KIT ENT 1125
K Number: K922126
·
Decision Jan 21, 1993
Classifications
1
FEI Numbers
285
Registration Numbers
286
Same Product Code
21
Applicant Total
7
Review Days
260
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
- HOSPITAL KIT ENT 1125
- K Number
- K922126
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Savoy Medical Supply Co., Inc.
- Date Received
- May 6, 1992
- Decision Date
- January 21, 1993
- Product Code
- LRP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRP | Tray, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRP), ordered by most recent decision date.
LACERATION TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EYE TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CUSTOM ENT PACKS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ORTHOPEDIC TRAY PRODUCT LINE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GENERAL SURGERY TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Savoy Medical Supply Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922133 | HOSPITAL KIT SV 105 | Jun 7, 1993 | Unknown |
| K922130 | HOSPITAL KIT DK 117 | May 24, 1993 | Unknown |
| K922127 | HOSPITAL KIT GP 103 | Mar 29, 1993 | Unknown |
| K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT | Mar 26, 1993 | Substantially Equivalent |
| K922128 | HOSPITAL KIT EP 104 | Mar 23, 1993 | Unknown |
| K923283 | SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT | Jan 4, 1993 | Unknown |