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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 K880838
Device Name BASSINET STAND WITH DRESSING TRAY
Applicant
Serv-Queen, Inc.
Box 10030
705 Fentress Blvd.
Daytona Beach,  FL  32014
Applicant Contact BEN SHENKER
Correspondent
Serv-Queen, Inc.
Box 10030
705 Fentress Blvd.
Daytona Beach,  FL  32014
Correspondent Contact BEN SHENKER
Regulation Number880.5140
Classification Product Code
FMS  
Date Received03/01/1988
Decision Date 04/29/1988
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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