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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K853604
Device Name ACE-KYLE DYE INJECTION NEEDLE P/N 14082
Applicant
Today'S Machining & Design, Inc.
2368 Eastman Ave. #14
Ventura,  CA  93002
Applicant Contact MARK WILSON
Correspondent
Today'S Machining & Design, Inc.
2368 Eastman Ave. #14
Ventura,  CA  93002
Correspondent Contact MARK WILSON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/28/1985
Decision Date 11/12/1985
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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