ULTRASOFT GOWN— 510(k) K800124

Substantially Equivalent

Mars Mfg Co.

FDA 510(k) clearance K800124 for ULTRASOFT GOWN, Substantially Equivalent on 1980-02-05. Applicant: Mars Mfg Co.. Device class: 2.

Clearance details

Applicant
Mars Mfg Co.
Product code
Code FYA
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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