FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAUZE BANDAGE ROLL
K Number: K914842
·
Decision Dec 4, 1991
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
11
Review Days
37
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Basic Information
- Device Name
- GAUZE BANDAGE ROLL
- K Number
- K914842
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cal West Trading Co.
- Date Received
- October 28, 1991
- Decision Date
- December 4, 1991
- Product Code
- NAB
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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STERILE GAUZE PADS
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Other Clearances by Cal West Trading Co.
| K Number | Device Name | ||
|---|---|---|---|
| K950392 | 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 | Feb 21, 1995 | Substantially Equivalent |
| K933756 | MAGNASHIELD CPR MOUTH BARRIER | Jan 5, 1994 | Substantially Equivalent |
| K920269 | EZ GAUZE SPONGE | Apr 22, 1992 | Substantially Equivalent |
| K912952 | BANDAGE COMPRESS | Oct 4, 1991 | Substantially Equivalent |
| K912950 | COMPRESS DRESSING | Oct 4, 1991 | Substantially Equivalent |
| K912953 | GAUZE COMPRESS | Sep 30, 1991 | Substantially Equivalent |
| K912955 | EYE PAD | Sep 10, 1991 | Substantially Equivalent |
| K912951 | 12-PLY GAUZE PAD | Sep 10, 1991 | Substantially Equivalent |
| K912954 | STRETCH GAUZE BANDAGE | Sep 10, 1991 | Substantially Equivalent |
| K912949 | TRIANGULAR BANDAGE,40 | Sep 6, 1991 | Substantially Equivalent |