FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOIL BABY BUNTING
K Number: K915303
·
Decision Feb 20, 1992
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
9
Review Days
91
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Basic Information
- Device Name
- FOIL BABY BUNTING
- K Number
- K915303
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gam Industries, Inc.
- Date Received
- November 21, 1991
- Decision Date
- February 20, 1992
- Product Code
- KME
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KME), ordered by most recent decision date.
READY-HEAT BLANKET
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OREX MEDICAL BEDDING
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DOCTOR DOWN --RESCUE WRAP
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AMERICAN BURN SHEET
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CHEM-SLEEVE B
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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 |
| K926290 | BURN SHEET | Apr 20, 1993 | Substantially Equivalent |
| K925590 | MULTI-TRAUMA DRESSING | Apr 8, 1993 | Substantially Equivalent |
| K915569 | UMBILICAL CLAMP | Sep 23, 1992 | Substantially Equivalent |