510(k) K932370

REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET by Remington Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1993
Date Received
May 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type