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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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