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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K915730
Device Name MORTARA INSTRUMENT ODEL ELI 50I
Applicant
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Applicant Contact PAUL S DONDERO
Correspondent
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Correspondent Contact PAUL S DONDERO
Classification Product Code
LOS
Date Received12/20/1991
Decision Date 11/10/1992
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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