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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 K951024
Device Name NATURE'S CRADLE
Applicant
Infant Advantage, Inc.
47800 Westinghouse Dr.
Fremont,  CA  94539
Applicant Contact GERALD V BEEMILLER
Correspondent
Infant Advantage, Inc.
47800 Westinghouse Dr.
Fremont,  CA  94539
Correspondent Contact GERALD V BEEMILLER
Regulation Number880.5140
Classification Product Code
FMS  
Date Received03/06/1995
Decision Date 06/05/1995
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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