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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 K913291
Device Name MODEL C386 ISOLETTE(R) INFANT INCUBATOR
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 Number880.5400
Classification Product Code
FMZ  
Date Received07/24/1991
Decision Date 11/13/1991
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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