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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 K852901
Device Name DOUBLE PUNCTURE INSTRUMENTS
Applicant
LASER, INC.
P.O. BOX 358
TOMBALL,  TX  77375
Applicant Contact WM.(BILL) PRZYBYLA
Correspondent
LASER, INC.
P.O. BOX 358
TOMBALL,  TX  77375
Correspondent Contact WM.(BILL) PRZYBYLA
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/09/1985
Decision Date 10/16/1985
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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