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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 K950051
Device Name BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B
Applicant
The Brewer Co.
13901 Main St.
P.O. Box 159
Menomonee Falls,  WI  53051
Applicant Contact JOSEPH H HANNES
Correspondent
The Brewer Co.
13901 Main St.
P.O. Box 159
Menomonee Falls,  WI  53051
Correspondent Contact JOSEPH H HANNES
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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