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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K850181
Device Name AEQUITRON MED-7100 PHOTOTHERAPY LIGHT
Applicant
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  MN  55447
Correspondent Contact ROBERT C SAMEC
Regulation Number880.5700
Classification Product Code
LBI  
Date Received01/18/1985
Decision Date 04/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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