FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GUAZE SPONGES, PLAIN
K Number: K820107
·
Decision Feb 12, 1982
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
20
Review Days
28
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Basic Information
- Device Name
- GUAZE SPONGES, PLAIN
- K Number
- K820107
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Stan-Pak Ent.
- Date Received
- January 15, 1982
- Decision Date
- February 12, 1982
- 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 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 |
| K820108 | TOPPER SPONGES | Feb 12, 1982 | Substantially Equivalent |
| K820155 | SPECIALIST CAST PADDING | Feb 12, 1982 | Substantially Equivalent |
| K820106 | X-RAY GUAZE SPONGES | 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 |