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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps
510(k) Number K840766
Device Name JANACEK TUBO-UTERINE IMPLANTATION SET
Applicant
Cimed Intl., Inc.
C/O Myron E. Sildon Associates
2800 City Ctr Sq./1100 Main St.
Kansas City,  MO  64105
Applicant Contact JAMES L KENWORTHY
Correspondent
Cimed Intl., Inc.
C/O Myron E. Sildon Associates
2800 City Ctr Sq./1100 Main St.
Kansas City,  MO  64105
Correspondent Contact JAMES L KENWORTHY
Regulation Number878.4800
Classification Product Code
HTD  
Date Received02/23/1984
Decision Date 04/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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