510(k) K033739

PHYSICIAN INDUSTRIES' DURAMETER SYRINGE by Physician Industries, Inc. — Product Code FMF

K033739 is an FDA 510(k) premarket notification submitted by Physician Industries, Inc. for the device "PHYSICIAN INDUSTRIES' DURAMETER SYRINGE". The FDA issued a decision of Substantially Equivalent on July 12, 2004. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Physician Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2004
Date Received
November 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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