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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tenaculum, uterine
510(k) Number K890379
Device Name UTERINE TENTACULUM
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 Number884.4530
Classification Product Code
HDC  
Date Received01/23/1989
Decision Date 02/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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