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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 K853355
Device Name N.K. PEDIATRIC CRIBS
Applicant
N.K. Medical Products, Inc.
5225 Sheridan Dr.
Williamsville,  NY  14221
Applicant Contact NORMAN V KURLANDER
Correspondent
N.K. Medical Products, Inc.
5225 Sheridan Dr.
Williamsville,  NY  14221
Correspondent Contact NORMAN V KURLANDER
Regulation Number880.5140
Classification Product Code
FMS  
Date Received08/12/1985
Decision Date 09/20/1985
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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