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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K851479
Device Name VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
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 Number868.5140
Classification Product Code
CAZ  
Date Received04/15/1985
Decision Date 06/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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