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510(k) K081720

PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS by Prime Herbs Corporation — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2009
Date Received
June 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

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