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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 K011549
Device Name OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
Applicant
Ohmeda Medical
8880 Gorman Rd.
Laurel,  MD  20723
Applicant Contact ALBERTO F PROFUMO
Correspondent
Ohmeda Medical
8880 Gorman Rd.
Laurel,  MD  20723
Correspondent Contact ALBERTO F PROFUMO
Regulation Number880.5700
Classification Product Code
LBI  
Date Received05/18/2001
Decision Date 07/19/2001
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
Recalls CDRH Recalls
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