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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 K993686
Device Name LIGHT PATCH
Applicant
Bioscan, Inc.
6 Walden Rd.
Corrales,  NM  87048
Applicant Contact BUTCH SMITH
Correspondent
Bioscan, Inc.
6 Walden Rd.
Corrales,  NM  87048
Correspondent Contact BUTCH SMITH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/01/1999
Decision Date 07/18/2000
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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