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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 K082511
Device Name MEDIGARD BLOOD COLLECTION DEVICE
Applicant
Medigard Limited
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact EJ Smith
Correspondent
Medigard Limited
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact EJ Smith
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/29/2008
Decision Date 01/16/2009
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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