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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K813133
Device Name KEYMED KEY LIGHT
Applicant
KEYMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KEYMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/05/1981
Decision Date 11/20/1981
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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