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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 K924517
Device Name AVITENE 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 Received09/04/1992
Decision Date 10/27/1993
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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