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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K883612
Device Name LECTROSPIRAL
Applicant
VYGON CORP.
1 MADISON ST.
EAST RUTHERFORD,  NJ  07073
Applicant Contact ROBERT G BROOKS
Correspondent
VYGON CORP.
1 MADISON ST.
EAST RUTHERFORD,  NJ  07073
Correspondent Contact ROBERT G BROOKS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/22/1988
Decision Date 09/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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