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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 K090308
Device Name RESTEP DVY SYSTEM, MODEL RSP-101
Applicant
STORTFORD MEDICAL LLC
295 PRINCETON HIGHTSTOWN ROAD
UNIT 321
WEST WINDSOR,  NJ  08550
Applicant Contact CHRIS DAUGHTERY
Correspondent
STORTFORD MEDICAL LLC
295 PRINCETON HIGHTSTOWN ROAD
UNIT 321
WEST WINDSOR,  NJ  08550
Correspondent Contact CHRIS DAUGHTERY
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/06/2009
Decision Date 05/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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