FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOPPER SPONGES
K Number: K820108
·
Decision Feb 12, 1982
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
20
Review Days
28
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
- TOPPER SPONGES
- K Number
- K820108
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Stan-Pak Ent.
- Date Received
- January 15, 1982
- Decision Date
- February 12, 1982
- Product Code
- NAB
- 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAB), ordered by most recent decision date.
IVALON EXTERNAL SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ISOLYER (4X4, 8PLY)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MULTI-TRAUMA DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
K-BAND AND K-CREPE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERILE GAUZE PADS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Stan-Pak Ent.
| K Number | Device Name | ||
|---|---|---|---|
| K823058 | DOSOMETRIC RELEASE STERILIZATION | Dec 9, 1982 | Substantially Equivalent |
| K820100 | FROSTED GLASS SLIDES | Mar 4, 1982 | Substantially Equivalent |
| K820099 | TRACH TAPE | Feb 23, 1982 | Substantially Equivalent |
| K820140 | WEBRIL CAST PADDING | Feb 12, 1982 | Substantially Equivalent |
| K820155 | SPECIALIST CAST PADDING | Feb 12, 1982 | Substantially Equivalent |
| K820106 | X-RAY GUAZE SPONGES | Feb 12, 1982 | Substantially Equivalent |
| K820107 | GUAZE SPONGES, PLAIN | Feb 12, 1982 | Substantially Equivalent |
| K820056 | TELFA STRIPS | Feb 5, 1982 | Substantially Equivalent |
| K820142 | TUBULAR STOCKINETTE | Feb 5, 1982 | Substantially Equivalent |
| K820139 | SOF-ROL CAST PADDING | Feb 5, 1982 | Substantially Equivalent |