FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BURN SHEET
K Number: K926290
·
Decision Apr 20, 1993
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
16
Applicant Total
9
Review Days
127
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Basic Information
- Device Name
- BURN SHEET
- K Number
- K926290
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5180
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gam Industries, Inc.
- Date Received
- December 14, 1992
- Decision Date
- April 20, 1993
- Product Code
- FPY
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FPY | Sheet, Burn | FDA class 1 | General Hospital |
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Other Clearances by Gam Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941641 | DISPOSABLE EMERGENCY OBSTETRICAL KIT | Oct 3, 1994 | Substantially Equivalent |
| K941336 | COMBO MASK | Sep 9, 1994 | Substantially Equivalent |
| K942021 | MOUTH TO MOUTH BREATHER | Jun 22, 1994 | Substantially Equivalent |
| K936050 | JAW SPREADER | Mar 24, 1994 | Substantially Equivalent |
| K930401 | ALUMINUM FOIL | May 12, 1993 | Substantially Equivalent |
| K925590 | MULTI-TRAUMA DRESSING | Apr 8, 1993 | Substantially Equivalent |
| K915569 | UMBILICAL CLAMP | Sep 23, 1992 | Substantially Equivalent |
| K915303 | FOIL BABY BUNTING | Feb 20, 1992 | Substantially Equivalent |