510(k) K011754

EXEL SECURETOUCH PTP SYRINGE by Exelint Intl. Co. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2003
Date Received
June 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type