IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069— 510(k) K950140
Substantially EquivalentPacesetter, Inc.
FDA 510(k) clearance K950140 for IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069, Substantially Equivalent on 1995-04-06. Applicant: Pacesetter, Inc.. Device class: 2.
Clearance details
- Applicant
- Pacesetter, 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
- Sylmar, CA, US
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