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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K120641
Device Name GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
Applicant
Global Medi Products
1083 Delware Ave.
Buffalo,  NY  14209
Applicant Contact ROBERT O DEAN
Correspondent
Global Medi Products
1083 Delware Ave.
Buffalo,  NY  14209
Correspondent Contact ROBERT O DEAN
Regulation Number880.5860
Classification Product Code
MEG  
Date Received03/02/2012
Decision Date 10/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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