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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K951683
Device Name A-V IMPULSE SYSTEM MODEL 6060
Applicant
Novamedix , Ltd.
Sixth Floor
1001 Pennsylvania Ave. NW
Washington,  DC  20004
Applicant Contact WILLIAM H.E. VON OEHSEN
Correspondent
Novamedix , Ltd.
Sixth Floor
1001 Pennsylvania Ave. NW
Washington,  DC  20004
Correspondent Contact WILLIAM H.E. VON OEHSEN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/11/1995
Decision Date 10/26/1995
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
Recalls CDRH Recalls
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