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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
510(k) Number K874705
Device Name EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number874.4680
Classification Product Code
JEJ  
Date Received11/19/1987
Decision Date 12/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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