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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 K982546
Device Name PHASER-2000
Applicant
DIOMEDICS, INC.
3817 S.W. 15TH ST.
GAINESVILLE,  FL  32608
Correspondent
DIOMEDICS, INC.
3817 S.W. 15TH ST.
GAINESVILLE,  FL  32608
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/21/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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