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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 K943017
Device Name NEONATAL RESTRAINT AND COMFORT SYSTEMS
Applicant
K.Bowmed, Inc.
P.O. Box 216
North Wilkesboro,  NC  28659
Applicant Contact KAROLEN C BOWMAN
Correspondent
K.Bowmed, Inc.
P.O. Box 216
North Wilkesboro,  NC  28659
Correspondent Contact KAROLEN C BOWMAN
Regulation Number880.5680
Classification Product Code
FRP  
Date Received06/24/1994
Decision Date 01/19/1995
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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