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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K990266
Device Name MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
Applicant
Micromedical Industries, Ltd.
189 Happ Rd.
Northfield,  IL  60093
Applicant Contact DEAN E SYNDER
Correspondent
Micromedical Industries, Ltd.
189 Happ Rd.
Northfield,  IL  60093
Correspondent Contact DEAN E SYNDER
Classification Product Code
LOS
Date Received01/28/1999
Decision Date 02/02/1999
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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