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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 K962482
Device Name SCUBA SYSTEM
Applicant
Gynecare, Inc.
235 Constitution Dr.
Menlo Park,  CA  94025
Applicant Contact MILTON B MCCOLL, M.D.
Correspondent
Gynecare, Inc.
235 Constitution Dr.
Menlo Park,  CA  94025
Correspondent Contact MILTON B MCCOLL, M.D.
Regulation Number884.1690
Classification Product Code
HIH  
Date Received06/26/1996
Decision Date 11/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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