510(k) K914608
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