UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER— 510(k) K896438
Substantially EquivalentTelectronics Pacing Systems, Inc.
FDA 510(k) clearance K896438 for UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER, Substantially Equivalent on 1990-04-10. Applicant: Telectronics Pacing Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Telectronics Pacing Systems, 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
- Englewood, CO, US
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