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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 K934286
Device Name HYSTEROSCOPE
Applicant
Bei Medical Systems Co., Inc.
83 Hobart St.
Hackensack,  NJ  07601
Applicant Contact H. PHILIP HOVNANIAN
Correspondent
Bei Medical Systems Co., Inc.
83 Hobart St.
Hackensack,  NJ  07601
Correspondent Contact H. PHILIP HOVNANIAN
Regulation Number884.1690
Classification Product Code
HIH  
Date Received09/02/1993
Decision Date 07/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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