TEFGEN-FD— 510(k) K935137

Substantially Equivalent

American Custom Medical, Inc.

FDA 510(k) clearance K935137 for TEFGEN-FD, Substantially Equivalent on 1994-08-15. Applicant: American Custom Medical, Inc.. Device class: 2.

Clearance details

Applicant
American Custom Medical, Inc.
Product code
Code NPK
Device class
Class 2
Regulation
21 CFR 872.3930
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lubbock, TX, US
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