NOVATEC PRM— 510(k) K790450

Substantially Equivalent

Novatec, Inc.

FDA 510(k) clearance K790450 for NOVATEC PRM, Substantially Equivalent on 1979-04-06. Applicant: Novatec, Inc.. Device class: 2.

Clearance details

Applicant: Novatec, Inc.
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 1979-03-05
Decision date: 1979-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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