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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 K942431
Device Name LAPOROSCOPIC SCISSORS
Applicant
Enterprise Medical Corp.
3214 Brassfield Rd., #2201
Greensboro,  NC  27410
Applicant Contact REUBEN MARGOLIASH
Correspondent
Enterprise Medical Corp.
3214 Brassfield Rd., #2201
Greensboro,  NC  27410
Correspondent Contact REUBEN MARGOLIASH
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/20/1994
Decision Date 10/11/1995
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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