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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 K844820
Device Name FLOW MED SK 140 BURET
Applicant
D.R.O. Medical, Inc.
210 E. 86 St.
New York,  NY  10028
Applicant Contact SONIA KLEINMANN
Correspondent
D.R.O. Medical, Inc.
210 E. 86 St.
New York,  NY  10028
Correspondent Contact SONIA KLEINMANN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/07/1984
Decision Date 01/28/1985
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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