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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 K960980
Device Name ISOLETTE INFANT INCUBATOR
Applicant
Air-Shields, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Applicant Contact MARCI L GOLDFINGER, M.S.B.M.E.
Correspondent
Air-Shields, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Correspondent Contact MARCI L GOLDFINGER, M.S.B.M.E.
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received03/11/1996
Decision Date 07/30/1996
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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