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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 K872742
Device Name WARM WEIGH MODELS I-20/W-30 INFANT SCALE
Applicant
Air-Shields, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Applicant Contact CHRISTIAN ANDREASEN
Correspondent
Air-Shields, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Correspondent Contact CHRISTIAN ANDREASEN
Regulation Number880.5130
Classification Product Code
FMT  
Date Received07/10/1987
Decision Date 10/20/1987
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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