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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K900162
Device Name DGH A-SAN PROBE HOLDER
Applicant
Jedmed Instrument Co.
1430 Hanley Industrial Ct.
St. Louis,  MO  63144
Applicant Contact CRAIG RAPP
Correspondent
Jedmed Instrument Co.
1430 Hanley Industrial Ct.
St. Louis,  MO  63144
Correspondent Contact CRAIG RAPP
Regulation Number884.5250
Classification Product Code
HDR  
Date Received01/12/1990
Decision Date 02/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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