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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stretcher, Wheeled
510(k) Number K895740
Device Name SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART
Applicant
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706
Applicant Contact WARREN WARTELL
Correspondent
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706
Correspondent Contact WARREN WARTELL
Regulation Number880.6910
Classification Product Code
FPO  
Date Received09/26/1989
Decision Date 02/22/1990
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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