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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name photocoagulator and accessories
510(k) Number K954308
Device Name GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
Applicant
GAMP & ASSOC.
15 FOXHUNT DR.
CHESTERFIELD,  MO  63017
Applicant Contact JAMES TAYLOR
Correspondent
GAMP & ASSOC.
15 FOXHUNT DR.
CHESTERFIELD,  MO  63017
Correspondent Contact JAMES TAYLOR
Regulation Number886.4690
Classification Product Code
HQB  
Date Received09/15/1995
Decision Date 12/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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