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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 K940316
Device Name HYSTERSCOPE
Applicant
Stephen Chakoff, Inc.
15405 Southwest 72 Ct.
Miami,  FL  33157
Applicant Contact FRANK GOLDFARB
Correspondent
Stephen Chakoff, Inc.
15405 Southwest 72 Ct.
Miami,  FL  33157
Correspondent Contact FRANK GOLDFARB
Regulation Number884.1690
Classification Product Code
HIH  
Date Received01/24/1994
Decision Date 11/16/1995
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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