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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K982620
Device Name MEDIVISION CYSTOSCOPE
Applicant
Medivision Scope Service Center, Inc.
1440 S. State College Blvd.
Suite 1c
Anaheim,  CA  92806
Applicant Contact WAYNE B STERNER
Correspondent
Medivision Scope Service Center, Inc.
1440 S. State College Blvd.
Suite 1c
Anaheim,  CA  92806
Correspondent Contact WAYNE B STERNER
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received07/27/1998
Decision Date 09/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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