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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K813027
Device Name STERILE IRRIGATING SYRINGES, KITS,TRAY
Applicant
Welcon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Welcon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received10/28/1981
Decision Date 11/20/1981
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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