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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K930083
Device Name EMS BIOPSY INSTRUMENT
Applicant
Engineered Medical Systems
8529 Zionsville Rd.
P.O. Box 681514
Indianapolis,  IN  46268
Applicant Contact JEFF QUINN
Correspondent
Engineered Medical Systems
8529 Zionsville Rd.
P.O. Box 681514
Indianapolis,  IN  46268
Correspondent Contact JEFF QUINN
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/07/1993
Decision Date 04/21/1993
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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