OPEN HEART TRAY (CUSTOM DESIGNED)— 510(k) K822158

Name: FDA 510(k) clearance K822158
Creator: U.S. Food and Drug Administration
Published: 1982-10-13

Substantially Equivalent

Megaplast, Inc.

FDA 510(k) clearance K822158 for OPEN HEART TRAY (CUSTOM DESIGNED), Substantially Equivalent on 1982-10-13. Applicant: Megaplast, Inc.. Device class: 1.

Clearance details

Applicant: Megaplast, Inc.
Product code: Code KDD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1982-07-23
Decision date: 1982-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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