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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 K884086
Device Name C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR
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 Received09/27/1988
Decision Date 11/14/1988
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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