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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mini Endoscope, Gastroenterology-Urology
510(k) Number K943593
Device Name SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM
Applicant
Ovamed Corp.
111 W. Evelyn Ave.,
Suite 214
Sunnyvale,  CA  94086
Applicant Contact JOHN ZINK
Correspondent
Ovamed Corp.
111 W. Evelyn Ave.,
Suite 214
Sunnyvale,  CA  94086
Correspondent Contact JOHN ZINK
Regulation Number876.1500
Classification Product Code
ODF  
Date Received07/25/1994
Decision Date 03/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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