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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 K934338
Device Name INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
Applicant
Innovasive Devices, Inc.
100 B S. St.
Hopkinton,  MA  01748
Applicant Contact ERIC BANNON
Correspondent
Innovasive Devices, Inc.
100 B S. St.
Hopkinton,  MA  01748
Correspondent Contact ERIC BANNON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/07/1993
Decision Date 02/10/1994
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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