PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV— 510(k) K031164
Substantially Equivalent - Subject to Tracking Reg.Oscor, Inc.
FDA 510(k) clearance K031164 for PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV, Substantially Equivalent - Subject to Tracking Reg. on 2003-06-19. Applicant: Oscor, Inc.. Device class: 2.
Clearance details
- Applicant
- Oscor, 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
- Palm Harbor, FL, US
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