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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nursing Pad, Cohesive Gel
510(k) Number K052858
Device Name SOOTHIES GEL PADS
Applicant
PURONXY, INC.
9853 PACIFIC HEIGHTS BLVD.
SUITE L
SAN DIEGO,  CA  92121
Applicant Contact LESLIE SEBASTAIN
Correspondent
PURONXY, INC.
9853 PACIFIC HEIGHTS BLVD.
SUITE L
SAN DIEGO,  CA  92121
Correspondent Contact LESLIE SEBASTAIN
Regulation Number880.5630
Classification Product Code
NXH  
Date Received10/11/2005
Decision Date 02/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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