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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 K012121
Device Name SECUREGUARD RETRACTABLE SAFETY SYRINGE
Applicant
SAFEGARD MEDICAL PRODUCTS, INC.
14802 HADLEIGH WAY
TAMPA,  FL  33624
Applicant Contact MIKE DAYTON
Correspondent
SAFEGARD MEDICAL PRODUCTS, INC.
14802 HADLEIGH WAY
TAMPA,  FL  33624
Correspondent Contact MIKE DAYTON
Regulation Number880.5860
Classification Product Code
MEG  
Date Received07/06/2001
Decision Date 10/24/2001
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
Recalls CDRH Recalls
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