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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 K993051
Device Name VERSALET 7700 CARE CENTER, MODEL # 7700
Applicant
Hill-Rom Air-Shields
330 Jacksonville Rd.
Hatboro,  PA  19040
Applicant Contact JAMES G CARPENTER
Correspondent
Hill-Rom Air-Shields
330 Jacksonville Rd.
Hatboro,  PA  19040
Correspondent Contact JAMES G CARPENTER
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received09/13/1999
Decision Date 02/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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