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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rongeur, Manual
510(k) Number K943583
Device Name KERRISON RONGEURS
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 Number882.4840
Classification Product Code
HAE  
Date Received07/22/1994
Decision Date 02/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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