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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K884624
Device Name MVL/MODULAB WITH PVR MODULE
Applicant
Life Sciences Manufacturing, Inc.
Airport Industrial Park
Box 37f
West Lebanon,  NH  03784
Applicant Contact CAMPBELL, MD
Correspondent
Life Sciences Manufacturing, Inc.
Airport Industrial Park
Box 37f
West Lebanon,  NH  03784
Correspondent Contact CAMPBELL, MD
Regulation Number870.2780
Classification Product Code
JOM  
Date Received11/04/1988
Decision Date 02/01/1989
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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