FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JAW SPREADER
K Number: K936050
·
Decision Mar 24, 1994
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
0
Applicant Total
9
Review Days
94
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Basic Information
- Device Name
- JAW SPREADER
- K Number
- K936050
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gam Industries, Inc.
- Date Received
- December 20, 1993
- Decision Date
- March 24, 1994
- Product Code
- KBW
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KBW | Screw, Oral | FDA class 1 | Ear, Nose, Throat |
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 |
| 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 |