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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 K932045
Device Name DISPOSABLE INSUFFLATION TUBING
Applicant
LASER, INC.
P.O. BOX 358
TOMBALL,  TX  77375
Applicant Contact KEITH PRZYBYLA
Correspondent
LASER, INC.
P.O. BOX 358
TOMBALL,  TX  77375
Correspondent Contact KEITH PRZYBYLA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/27/1993
Decision Date 09/23/1993
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
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