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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Manual
510(k) Number K892877
Device Name CRADLE, HOSPITAL BED CLOTHING
Applicant
Warsaw Orthopedic, Inc.
P.O. Box 1157
Warsaw,  IN  46580
Applicant Contact JAMES RITTER
Correspondent
Warsaw Orthopedic, Inc.
P.O. Box 1157
Warsaw,  IN  46580
Correspondent Contact JAMES RITTER
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received04/19/1989
Decision Date 06/15/1989
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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