A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE— 510(k) K970388

Substantially Equivalent - Subject to Tracking & PMS

Biotronik, Inc.

FDA 510(k) clearance K970388 for A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE, Substantially Equivalent - Subject to Tracking & PMS on 1997-08-14. Applicant: Biotronik, Inc..

Clearance details

Applicant: Biotronik, Inc.
Product code: Code DTD
Advisory panel: Cardiovascular
Date received: 1997-02-03
Decision date: 1997-08-14
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Lake Oswego, OR, US

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