510(k) K914608

BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 by Dlp, Inc. — Product Code GAA

K914608 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120". The FDA issued a decision of Substantially Equivalent on January 9, 1992. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Dlp, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1992
Date Received
October 17, 1991
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