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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Teaching, For Endoscope
510(k) Number K935247
Device Name JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER
Applicant
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129
Applicant Contact CRAIG R PARKS
Correspondent
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129
Correspondent Contact CRAIG R PARKS
Regulation Number876.1500
Classification Product Code
FEA  
Date Received11/01/1993
Decision Date 02/18/1994
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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