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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar, Gastro-Urology
510(k) Number K904638
Device Name TROCAR DISPOSABLE
Applicant
L.A.S.E.R., Inc.
P.O. Box 358
Tomball,  TX  77375
Applicant Contact WILLIAM J PRZYBYLA
Correspondent
L.A.S.E.R., Inc.
P.O. Box 358
Tomball,  TX  77375
Correspondent Contact WILLIAM J PRZYBYLA
Regulation Number876.5090
Classification Product Code
FBQ  
Date Received10/11/1990
Decision Date 02/21/1991
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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