ACE/KYLE SELF TAPPING CANNULATED TITA
FDA 510(k) clearance K833866 · decided 1983-12-27
Clearance details
- K-number
- K833866
- Device name
- ACE/KYLE SELF TAPPING CANNULATED TITA
- Applicant
- Buckman Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-07
- Decision date
- 1983-12-27
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- JPW
- Device class
- 1
- Regulation number
- 874.5220
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.