PERMATHANE 865 & 867 UNIPOLAR POLYURETH— 510(k) K843703
Substantially EquivalentPacesetter Systems
FDA 510(k) clearance K843703 for PERMATHANE 865 & 867 UNIPOLAR POLYURETH, Substantially Equivalent on 1985-01-08. Applicant: Pacesetter Systems. Device class: 2.
Clearance details
- Applicant
- Pacesetter Systems
- 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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More clearances from Pacesetter Systems
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