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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 K915378
Device Name WECK TROCAR
Applicant
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Applicant Contact GLENN MATTEI
Correspondent
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Correspondent Contact GLENN MATTEI
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/29/1991
Decision Date 06/29/1992
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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