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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K915658
Device Name SPECTRA ECG
Applicant
Advanced Medical Products, Inc.
4709 Crossroads Park Dr.
Liverpool,  NY  13088
Applicant Contact KEVIN WORTEL
Correspondent
Advanced Medical Products, Inc.
4709 Crossroads Park Dr.
Liverpool,  NY  13088
Correspondent Contact KEVIN WORTEL
Classification Product Code
LOS
Date Received12/18/1991
Decision Date 06/10/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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