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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 K964188
Device Name HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT
Applicant
Healthcare Service and Supply
P.O. Box 1788
Tustin,  CA  92681
Applicant Contact RICK ROEDER
Correspondent
Healthcare Service and Supply
P.O. Box 1788
Tustin,  CA  92681
Correspondent Contact RICK ROEDER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/21/1996
Decision Date 05/06/1997
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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