AMBIDERM— 510(k) K971102

Substantially Equivalent

Supertex Industrial, S.A. DE C.V.

FDA 510(k) clearance K971102 for AMBIDERM, Substantially Equivalent on 1997-08-29. Applicant: Supertex Industrial, S.A. DE C.V.. Device class: 1.

Clearance details

Applicant
Supertex Industrial, S.A. DE C.V.
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Zapopan, Jalisco, MX
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