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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 K845004
Device Name CRIB CUDDLE - INFANT BED
Applicant
International Purchasing Services
P.O. Box 934
Newbury Park,  CA  91320
Applicant Contact IAN J MCGUGAN
Correspondent
International Purchasing Services
P.O. Box 934
Newbury Park,  CA  91320
Correspondent Contact IAN J MCGUGAN
Regulation Number880.5140
Classification Product Code
FMS  
Date Received12/26/1984
Decision Date 04/23/1986
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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