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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K944119
Device Name SURE-FLO IRRIGATION Y TUBING SET
Applicant
O.R. Resources, Inc.
P.O. Box 6563
Annapolis,  MD  21401
Applicant Contact STEVEN P LINDSEY
Correspondent
O.R. Resources, Inc.
P.O. Box 6563
Annapolis,  MD  21401
Correspondent Contact STEVEN P LINDSEY
Regulation Number878.4780
Classification Product Code
JCX  
Date Received08/23/1994
Decision Date 12/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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