SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300’S,380-300’S,390-300’S


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K022099
Device Name SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300’S,380-300’S,390-300’S
Original Applicant
HDC CORP.
555 thirteenth street, n.w.
washington, 
DC 
20004 -1109

Original Contact jonathan s kahan
Regulation Number 880.5200
Classification Product Code
FOZ  
Subsequent Product Code
DYB  
Date Received 06/27/2002
Decision Date 09/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No