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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 K932695
Device Name ISI(R) PORPOISE NOSE DISSECTING FORCEPS
Applicant
Innovative Surgical, Inc.
3071 Continental Dr.,
Suite 102
West Palm Beach,  FL  33407
Applicant Contact MARK C HAMBLIN
Correspondent
Innovative Surgical, Inc.
3071 Continental Dr.,
Suite 102
West Palm Beach,  FL  33407
Correspondent Contact MARK C HAMBLIN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/03/1993
Decision Date 03/03/1994
Decision Substantially Equivalent (SESE)
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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