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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K070936
Device Name WELMED HYPODERMIC SYRINGE
Applicant
Welmed, Inc.
15637 Fox Cove Cir.
Mosely,  VA  23120
Applicant Contact DARREN REEVES
Correspondent
Welmed, Inc.
15637 Fox Cove Cir.
Mosely,  VA  23120
Correspondent Contact DARREN REEVES
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/03/2007
Decision Date 07/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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