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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K931561
Device Name TROCAR SLEEVE
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 Number884.1720
Classification Product Code
HET  
Date Received03/30/1993
Decision Date 02/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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