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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 K932648
Device Name QUICK SWITCH LAPAROSCOPIC INSTRUMENTS
Applicant
Microline Pentax, Inc.
199 Newbury St.
Devers,  MA  01923
Applicant Contact DE LAFORCADE
Correspondent
Microline Pentax, Inc.
199 Newbury St.
Devers,  MA  01923
Correspondent Contact DE LAFORCADE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/02/1993
Decision Date 10/12/1993
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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