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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 K111748
Device Name RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A
Applicant
JOY LONG
7750 ZIONSVILLE RD
# 850
INDIANAPOLIS,  IN  46268
Applicant Contact JOY LONG
Correspondent
JOY LONG
7750 ZIONSVILLE RD
# 850
INDIANAPOLIS,  IN  46268
Correspondent Contact JOY LONG
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/22/2011
Decision Date 11/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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