3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100— 510(k) K900605

Name: FDA 510(k) clearance K900605
Creator: U.S. Food and Drug Administration
Published: 1990-03-06

Substantially Equivalent

Possis Medical, Inc.

FDA 510(k) clearance K900605 for 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100, Substantially Equivalent on 1990-03-06. Applicant: Possis Medical, Inc.. Device class: 2.

Clearance details

Applicant: Possis Medical, Inc.
Product code: Code DTD
Device class: Class 2
Regulation: 21 CFR 870.3620
Advisory panel: Cardiovascular
Date received: 1990-02-08
Decision date: 1990-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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