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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Pediatric Open Hospital
510(k) Number K860596
Device Name SWEET DREEMS SIMULATOR
Applicant
Sweet Dreams, Inc.
300 E. Wilson Bridge Rd.
Suite 275
Worthington,  OH  43085
Applicant Contact ARMANDO A CUERVO
Correspondent
Sweet Dreams, Inc.
300 E. Wilson Bridge Rd.
Suite 275
Worthington,  OH  43085
Correspondent Contact ARMANDO A CUERVO
Regulation Number880.5140
Classification Product Code
FMS  
Date Received02/19/1986
Decision Date 03/06/1986
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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