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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K772134
Device Name SYRINGE, IRRIGATION, PRE-FILLED
Applicant
Kendall Research Center
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kendall Research Center
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.4730
Classification Product Code
KOA  
Date Received11/14/1977
Decision Date 11/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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