FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BURN COMPRESS
K Number: K935932
·
Decision Jan 14, 1994
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
19
Review Days
32
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Basic Information
- Device Name
- BURN COMPRESS
- K Number
- K935932
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mcneil Healthcare, Inc.
- Date Received
- December 13, 1993
- Decision Date
- January 14, 1994
- 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 Mcneil Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935883 | NEUROLOGICAL SPONGES | Feb 3, 1994 | Substantially Equivalent |
| K935930 | NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING | Feb 3, 1994 | Substantially Equivalent |
| K935993 | SURGICAL SPONGE X-RAY DETECTABLE | Feb 2, 1994 | Substantially Equivalent |
| K935934 | NON ADHERANT BURN PADS | Jan 31, 1994 | Substantially Equivalent |
| K935910 | X-RAY PACKING SPONGE | Jan 31, 1994 | Substantially Equivalent |
| K935911 | PACKING SPONGE | Jan 31, 1994 | Substantially Equivalent |
| K935881 | SPECIALTY SPONGES | Jan 31, 1994 | Substantially Equivalent |
| K935882 | TONSIL SPONGES | Jan 31, 1994 | Substantially Equivalent |
| K935933 | CUSTOM BURN DRESSING | Jan 14, 1994 | Substantially Equivalent |
| K935936 | CONFORMING ROLL | Jan 14, 1994 | Substantially Equivalent |