SOF. PRESS EPC 51 SYSTEM— 510(k) K963067

Name: FDA 510(k) clearance K963067
Creator: U.S. Food and Drug Administration
Published: 1997-01-28

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K963067 for SOF. PRESS EPC 51 SYSTEM, Substantially Equivalent on 1997-01-28. Applicant: Gaymar Industries, Inc.. Device class: 2.

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1996-08-07
Decision date: 1997-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Download summary PDF View on FDA.gov ↗

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