510(k) K022099

SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S by Hdc Corp. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2002
Date Received
June 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type