JAW SPREADER
FDA 510(k) clearance K936050 · decided 1994-03-24
Clearance details
- K-number
- K936050
- Device name
- JAW SPREADER
- Applicant
- Gam Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-20
- Decision date
- 1994-03-24
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- KBW
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Petersburg, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.