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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K853625
Device Name NOVA ARTERIAL EMBOLECTOMY CATHETER
Applicant
Nova Medical Specialties
449 Oakshade Rd.
Indian Mills,  NJ  08088
Applicant Contact JOSEPH C GRIFFIN
Correspondent
Nova Medical Specialties
449 Oakshade Rd.
Indian Mills,  NJ  08088
Correspondent Contact JOSEPH C GRIFFIN
Regulation Number870.5150
Classification Product Code
DXE  
Date Received08/29/1985
Decision Date 01/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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