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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K060134
Device Name APOLLO IR HEAT LAMP SYSTEM
Applicant
APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL
12101 CULLEN BLVD.
SUITE A
HOUSTON,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL
12101 CULLEN BLVD.
SUITE A
HOUSTON,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received01/18/2006
Decision Date 03/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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