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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K952584
Device Name GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK
Applicant
Gamp & Assoc.
3237 Haas
Bridgeton,  MO  63044
Applicant Contact JAMES TAYLOR
Correspondent
Gamp & Assoc.
3237 Haas
Bridgeton,  MO  63044
Correspondent Contact JAMES TAYLOR
Regulation Number876.1500
Classification Product Code
MPA  
Date Received06/05/1995
Decision Date 09/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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