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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 K882761
Device Name TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)
Applicant
Intramed Laboratories, Inc.
11100 Roselle St.
San Diego,  CA  92121
Applicant Contact STEPHEN A SOSNOWSKI
Correspondent
Intramed Laboratories, Inc.
11100 Roselle St.
San Diego,  CA  92121
Correspondent Contact STEPHEN A SOSNOWSKI
Regulation Number884.1690
Classification Product Code
HIH  
Date Received07/06/1988
Decision Date 09/20/1988
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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