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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 K970878
Device Name ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT
Applicant
American Medical Devices, Inc.
1100 Northside Dr.
Atlanta,  GA  30318
Applicant Contact FRANK J TIGHE
Correspondent
American Medical Devices, Inc.
1100 Northside Dr.
Atlanta,  GA  30318
Correspondent Contact FRANK J TIGHE
Regulation Number876.1500
Classification Product Code
MPA  
Date Received03/10/1997
Decision Date 05/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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