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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K912910
Device Name C100 INFANT INCUBATOR SHELF/MOUNT RAIL 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 Number880.5400
Classification Product Code
FMZ  
Date Received07/02/1991
Decision Date 10/30/1991
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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