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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 K925949
Device Name PEDICRAGT BASSINET
Applicant
Pedicraft, Inc.
2014 Perry Place
Jacksonville,  FL  32207
Applicant Contact ERIC NORD
Correspondent
Pedicraft, Inc.
2014 Perry Place
Jacksonville,  FL  32207
Correspondent Contact ERIC NORD
Regulation Number880.5140
Classification Product Code
FMS  
Date Received11/24/1992
Decision Date 04/20/1993
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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