FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CONVERTORS STERILE DISP. LAP SPONGE II
K Number: K813296
·
Decision Dec 29, 1981
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
19
Review Days
36
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Basic Information
- Device Name
- CONVERTORS STERILE DISP. LAP SPONGE II
- K Number
- K813296
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- American Convertors Div., American Pharmaseal
- Date Received
- November 23, 1981
- Decision Date
- December 29, 1981
- 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 Convertors Div., American Pharmaseal
| K Number | Device Name | ||
|---|---|---|---|
| K840957 | ANTIMICROBIAL INCISE DRAPE | Jun 7, 1984 | Substantially Equivalent |
| K832137 | CONVERTORS FLASH STERILIZING TRAY | Aug 12, 1983 | Substantially Equivalent |
| K830786 | DISIMETRIC RELEASE OF INSTRANETICS RAD | May 18, 1983 | Substantially Equivalent |
| K820994 | ABSORB FURN SHEET | May 13, 1982 | Substantially Equivalent |
| K813419 | COMFORT CUSHION DRY BURN PAD III | Jan 22, 1982 | Substantially Equivalent |
| K813078 | CONTURA DISPOS. SURG. FACE MASK | Dec 18, 1981 | Substantially Equivalent |
| K812554 | TOMAC STERILE DISP. LAP SPONGE | Sep 24, 1981 | Substantially Equivalent |
| K802919 | ISO-BAC INSTRUMENT WRAP | Feb 2, 1981 | Substantially Equivalent |
| K802998 | PATIENT CARE DISPOSABLE INFANT SHIRTS | Dec 22, 1980 | Substantially Equivalent |
| K802359 | DISP. FENESTRATED SURG. DRAPE SHEETS | Oct 31, 1980 | Substantially Equivalent |