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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K951735
Device Name JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL
Applicant
Joerns Healthcare, Inc.
5001 Joerns Dr.
Stevens Point,  WI  54481 -5040
Applicant Contact MARK GRACE
Correspondent
Joerns Healthcare, Inc.
5001 Joerns Dr.
Stevens Point,  WI  54481 -5040
Correspondent Contact MARK GRACE
Regulation Number880.5100
Classification Product Code
FNL  
Date Received04/14/1995
Decision Date 08/18/1995
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
Recalls CDRH Recalls
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