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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K873041
Device Name A-V RECORDER
Applicant
Life Sciences Manufacturing, Inc.
Airport Industrial Park
Box 37f
West Lebanon,  NH  03784
Applicant Contact JAMES H VEZINA
Correspondent
Life Sciences Manufacturing, Inc.
Airport Industrial Park
Box 37f
West Lebanon,  NH  03784
Correspondent Contact JAMES H VEZINA
Regulation Number870.2120
Classification Product Code
DPT  
Date Received08/04/1987
Decision Date 02/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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