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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 K914461
Device Name A-V IMPULSE SYSTEM
Applicant
Novamedix , Ltd.
C/O Powell-Goldstein Fraz-Murp
1001 Pennsylvania Ave., NW
Washington,  DC  20004
Applicant Contact THOMAS M ANTONE
Correspondent
Novamedix , Ltd.
C/O Powell-Goldstein Fraz-Murp
1001 Pennsylvania Ave., NW
Washington,  DC  20004
Correspondent Contact THOMAS M ANTONE
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/07/1991
Decision Date 04/15/1992
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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