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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K864000
Device Name FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
Applicant
Fiberoptic Sensor Technlogies, Inc.
1158 S. Main St.
Plymouth,  MI  48170
Applicant Contact STEPHEN SHULMAN
Correspondent
Fiberoptic Sensor Technlogies, Inc.
1158 S. Main St.
Plymouth,  MI  48170
Correspondent Contact STEPHEN SHULMAN
Regulation Number870.2870
Classification Product Code
DXO  
Date Received10/14/1986
Decision Date 01/16/1987
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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