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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 K912908
Device Name AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM
Applicant
Air-Shields Vickers, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Applicant Contact FRANCIS X CASEY
Correspondent
Air-Shields Vickers, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Correspondent Contact FRANCIS X CASEY
Regulation Number880.5700
Classification Product Code
LBI  
Date Received07/02/1991
Decision Date 12/13/1991
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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