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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 K890218
Device Name MICROSURGICAL CYSTOTOME
Applicant
Kinetic Medical Products
4934 Peach St.
Erie,  PA  16509
Applicant Contact JAMES I LAUGHNER
Correspondent
Kinetic Medical Products
4934 Peach St.
Erie,  PA  16509
Correspondent Contact JAMES I LAUGHNER
Regulation Number876.4730
Classification Product Code
KOA  
Date Received01/18/1989
Decision Date 01/27/1989
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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