FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
VAGINAL PACKING
K Number: K792431
·
Decision Dec 27, 1979
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
270
Applicant Total
33
Review Days
29
Basic Information
- Device Name
- VAGINAL PACKING
- K Number
- K792431
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN MEDICAL DISPOSABLE, INC.
- Date Received
- November 28, 1979
- Decision Date
- December 27, 1979
- Product Code
- EFQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by AMERICAN MEDICAL DISPOSABLE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K833735 | AN ODOR ABSORBENT BANDAGE | Apr 23, 1984 | Substantially Equivalent |
| K833734 | NEUROLOGICAL SPONGE ON PLASTIC STICK | Apr 23, 1984 | Substantially Equivalent |
| K833731 | BREATHABLE OVERWRAY BANDAGE NON-ELAS | Jan 27, 1984 | Substantially Equivalent |
| K833730 | NON ADHERENT BANDAGE/SHEET | Jan 27, 1984 | Substantially Equivalent |
| K833729 | ELASTIC BREATHABLE OVER-WRAP BANDAGE | Dec 30, 1983 | Substantially Equivalent |
| K833733 | NON - ADHERENT BANDAGE | Dec 27, 1983 | Substantially Equivalent |
| K833732 | NON WETTING UNDERCAST PADDING | Dec 12, 1983 | Substantially Equivalent |
| K830201 | POLYESTER X-RAY DETECTABLE STRUNG-SPONGE | Feb 23, 1983 | Substantially Equivalent |
| K830202 | COTTON BALLS, X-RAY OPAQUED STRUNG & NON | Feb 23, 1983 | Substantially Equivalent |
| K803116 | HEAVY DRAINAGE PACK | Jan 28, 1981 | Substantially Equivalent |