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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 K950059
Device Name MC INFANT CARE UNIE #PP30
Applicant
Janco Consulting Services
6839 Montevideo Rd.
Mississauga, Ontario
L5n 1n7,  CA L5N 1N7
Applicant Contact JANET C SHAW
Correspondent
Janco Consulting Services
6839 Montevideo Rd.
Mississauga, Ontario
L5n 1n7,  CA L5N 1N7
Correspondent Contact JANET C SHAW
Regulation Number880.5140
Classification Product Code
FMS  
Date Received01/06/1995
Decision Date 02/10/1995
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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