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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K952392
Device Name MLI SET
Applicant
Medical Technologies of Georgia
5335-A Dividend Dr.
Decatur,  GA  30035
Applicant Contact DEANNA GETTLER
Correspondent
Medical Technologies of Georgia
5335-A Dividend Dr.
Decatur,  GA  30035
Correspondent Contact DEANNA GETTLER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/22/1995
Decision Date 08/07/1995
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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