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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
Recalls CDRH Recalls
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