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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 K936235
Device Name NEEDLESAFE II & NEEDLEGARD II
Applicant
Ingenious Technologies Corp.
556 Roxbury Ave., NW
Massillon,  OH  44646
Applicant Contact EDWARD D LIN
Correspondent
Ingenious Technologies Corp.
556 Roxbury Ave., NW
Massillon,  OH  44646
Correspondent Contact EDWARD D LIN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/24/1993
Decision Date 03/28/1994
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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