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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 K911744
Device Name PRECISION OPTICS CORPORATION LAPAROSCOPE
Applicant
PRECISE OPTICS
22 EAST BROADWAY
GARDNER,  MA  01440
Applicant Contact FRANCIS L.PUGSLEY
Correspondent
PRECISE OPTICS
22 EAST BROADWAY
GARDNER,  MA  01440
Correspondent Contact FRANCIS L.PUGSLEY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/18/1991
Decision Date 07/26/1991
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
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