BK-A; BK-B; BK-IS SEALING CAP— 510(k) K970204
Substantially EquivalentBiotronik, Inc.
FDA 510(k) clearance K970204 for BK-A; BK-B; BK-IS SEALING CAP, Substantially Equivalent on 1997-04-29. 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
- Clearance type
- Traditional
- Location
- Lake Oswego, OR, US
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