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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K802369
Device Name 12SSL ECG ANALYSIS PROG.(SCALER LEAD)
Applicant
Marquette Electronics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Marquette Electronics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LOS
Date Received09/29/1980
Decision Date 11/12/1980
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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