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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 K821773
Device Name PEDICRAFT BED, MODEL B2944
Applicant
PEDICRAFT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PEDICRAFT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5140
Classification Product Code
FMS  
Date Received06/16/1982
Decision Date 06/23/1982
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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