510(k) K896605

KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) by National-Standard Medical Products — Product Code GAA

K896605 is an FDA 510(k) premarket notification submitted by National-Standard Medical Products for the device "KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG)". The FDA issued a decision of Substantially Equivalent on January 4, 1990. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. National-Standard Medical Products has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
November 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type