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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K870067
Device Name MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20
Applicant
Vygon Corp.
1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact TONY J RIVERS
Correspondent
Vygon Corp.
1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact TONY J RIVERS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/08/1987
Decision Date 04/28/1987
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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