BK-N SEALING CAP— 510(k) K971930
Substantially Equivalent - Subject to Tracking & PMSBiotronik, Inc.
FDA 510(k) clearance K971930 for BK-N SEALING CAP, Substantially Equivalent - Subject to Tracking & PMS on 1997-08-14. Applicant: Biotronik, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotronik, Inc.
- Product code
- Code DTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3620
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking & PMS
- Clearance type
- Traditional
- Location
- Lake Oswego, OR, US
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