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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K940951
FOIA Releasable 510(k) K940951
Device Name RW RESUCITAIRE INFANT RADIANT WARMER
Applicant
Air-Shields, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Applicant Contact FRANCIS X CASEY
Correspondent
Air-Shields, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Correspondent Contact FRANCIS X CASEY
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/02/1994
Decision Date 05/03/1995
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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