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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 K964450
Device Name SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
Applicant
PILLING WECK GROUP
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
PILLING WECK GROUP
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/06/1996
Decision Date 01/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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