FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ABSORBENT PAD CAT.#729, 732, 730, 731
K Number: K802005
·
Decision Sep 16, 1980
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
31
Review Days
27
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
- ABSORBENT PAD CAT.#729, 732, 730, 731
- K Number
- K802005
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Pollak (Intl.), Ltd.
- Date Received
- August 20, 1980
- Decision Date
- September 16, 1980
- 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 Pollak (Intl.), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K000227 | UMBICUT | Apr 27, 2000 | Substantially Equivalent |
| K810049 | PEDICAT* | Apr 21, 1981 | Substantially Equivalent |
| K810050 | VECAFIX* | Mar 26, 1981 | Substantially Equivalent |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | Oct 31, 1980 | Substantially Equivalent |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | Oct 31, 1980 | Substantially Equivalent |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | Oct 10, 1980 | Substantially Equivalent |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | Sep 26, 1980 | Substantially Equivalent |
| K801991 | PLASTIC FORCEPS CAT.#1001-1010 | Sep 16, 1980 | Substantially Equivalent |
| K801996 | GUAZE BANDAGES CAT.#101-169 | Sep 16, 1980 | Substantially Equivalent |
| K802021 | PEDIBAND CAT.#195-197 | Sep 16, 1980 | Substantially Equivalent |