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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K920965
Device Name STRAIGHT-LINES I.V. ORGANIZER
Applicant
Taylor Bio-Medical, Inc.
5541 Railroad Grade Rd.
Alpena,  MI  49707
Applicant Contact JULIA TAYLOR
Correspondent
Taylor Bio-Medical, Inc.
5541 Railroad Grade Rd.
Alpena,  MI  49707
Correspondent Contact JULIA TAYLOR
Regulation Number880.6500
Classification Product Code
FRA  
Date Received03/02/1992
Decision Date 04/07/1993
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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