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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bell, Circumcision
510(k) Number K911272
Device Name ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705
Applicant
Edward Weck, Inc.
P.O. Box 12600
Weck Dr.
Research Triangle Pa,  NC  27709
Applicant Contact GLENN M MATTEI
Correspondent
Edward Weck, Inc.
P.O. Box 12600
Weck Dr.
Research Triangle Pa,  NC  27709
Correspondent Contact GLENN M MATTEI
Regulation Number884.4530
Classification Product Code
FHG  
Date Received03/22/1991
Decision Date 07/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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