AUGUSTINE GUIDE KIT
FDA 510(k) clearance K921166 · decided 1992-04-23
Clearance details
- K-number
- K921166
- Device name
- AUGUSTINE GUIDE KIT
- Applicant
- Augustine Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-11
- Decision date
- 1992-04-23
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- CCW
- Device class
- 1
- Regulation number
- 868.5540
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.