A1-CS-SB Y-ADAPTER, MODEL 124 871— 510(k) K003454
Substantially Equivalent - Subject to Tracking Reg.Biotronik, Inc.
FDA 510(k) clearance K003454 for A1-CS-SB Y-ADAPTER, MODEL 124 871, Substantially Equivalent - Subject to Tracking Reg. on 2001-01-18. 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 Reg.
- Clearance type
- Special
- Location
- Lake Oswego, OR, US
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