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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K943828
Device Name STERILE WATER FOR IRRIGATION
Applicant
Orion Life Systems, Inc.
P.O. Box 2308
Palm Harbor,  FL  34682 -2308
Applicant Contact PATRICK J LAMB
Correspondent
Orion Life Systems, Inc.
P.O. Box 2308
Palm Harbor,  FL  34682 -2308
Correspondent Contact PATRICK J LAMB
Regulation Number880.6740
Classification Product Code
JOL  
Date Received08/05/1994
Decision Date 11/21/1994
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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