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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 K914084
Device Name ENDOSCOPES
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 Received09/04/1991
Decision Date 01/22/1992
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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