FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMBO MASK
K Number: K941336
·
Decision Sep 9, 1994
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
12
Applicant Total
9
Review Days
172
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Basic Information
- Device Name
- COMBO MASK
- K Number
- K941336
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5570
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gam Industries, Inc.
- Date Received
- March 21, 1994
- Decision Date
- September 9, 1994
- Product Code
- KGB
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| KGB | Mask, Oxygen, Non-Rebreathing | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGB), ordered by most recent decision date.
POCKET RESCUE
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CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
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COMPACT MASK
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NONREBREATHING VALVE
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LAERDAL(TM) POCKET MASK, MODIFICATION
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Other Clearances by Gam Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941641 | DISPOSABLE EMERGENCY OBSTETRICAL KIT | Oct 3, 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 |
| K915303 | FOIL BABY BUNTING | Feb 20, 1992 | Substantially Equivalent |