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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 K910985
Device Name SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
Applicant
Precision Laser Products, Inc.
702 Simmons Rd.
Sellersville,  PA  18960
Applicant Contact PERK CROOK
Correspondent
Precision Laser Products, Inc.
702 Simmons Rd.
Sellersville,  PA  18960
Correspondent Contact PERK CROOK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/06/1991
Decision Date 07/05/1991
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
Predetermined Change
Control Plan Authorized		 No
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