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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K040772
Device Name PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
Applicant
Penner Manufacturing, Inc.
1500 Woodmen Tower
Ohaha,  NE  68102
Applicant Contact VICKIE J BRADY
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received03/26/2004
Decision Date 04/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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