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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K982659
Device Name MEDIVISION HYSTEROSCOPE
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 Number884.1690
Classification Product Code
HIH  
Date Received07/30/1998
Decision Date 10/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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