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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Infant Position
510(k) Number K882544
Device Name CUDDLE UP PILLOW
Applicant
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Applicant Contact CYNTHIA B SIBREL
Correspondent
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Correspondent Contact CYNTHIA B SIBREL
Regulation Number880.5680
Classification Product Code
FRP  
Date Received06/21/1988
Decision Date 01/31/1989
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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