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510(k) K790444

ELECATH MULTI-PURPOSE ARTERIAL SURGER by Electro-Catheter Corp. — Product Code GBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1979
Date Received
March 6, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Balloon Type
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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