PETERS CARDIOFLON(TM) SUTURE— 510(k) K913101

Name: FDA 510(k) clearance K913101
Creator: U.S. Food and Drug Administration
Published: 1992-08-12

Substantially Equivalent

Promedica Products, Inc.

FDA 510(k) clearance K913101 for PETERS CARDIOFLON(TM) SUTURE, Substantially Equivalent on 1992-08-12. Applicant: Promedica Products, Inc.. Device class: 2.

Clearance details

Applicant: Promedica Products, Inc.
Product code: Code GAS
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 1991-07-12
Decision date: 1992-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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