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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 K930610
Device Name TALC DISPENSER SYRINGE
Applicant
Nusurg, Inc.
7432 Jager Ct.
Cincinnati,  OH  45230
Applicant Contact DENNIS R LACKEY
Correspondent
Nusurg, Inc.
7432 Jager Ct.
Cincinnati,  OH  45230
Correspondent Contact DENNIS R LACKEY
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received02/05/1993
Decision Date 11/04/1993
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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