510(k) K970803

ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE by Retractable Technologies, Inc. — Product Code MEG

K970803 is an FDA 510(k) premarket notification submitted by Retractable Technologies, Inc. for the device "ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE". The FDA issued a decision of Substantially Equivalent on May 29, 1997. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Retractable Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1997
Date Received
March 4, 1997
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