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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K932692
Device Name INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT
Applicant
Innerdyne Medical, Inc.
2665 Marine Way
Mountain View,  CA  94043
Applicant Contact COLIN J NICHOL
Correspondent
Innerdyne Medical, Inc.
2665 Marine Way
Mountain View,  CA  94043
Correspondent Contact COLIN J NICHOL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/03/1993
Decision Date 12/27/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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