Breast Les Local Wire St. 48219/49220/48119/48120
FDA 510(k) K914608 · Dlp, Inc.
510(k) numberK914608
Submission
- Device name
- Breast Les Local Wire St. 48219/49220/48119/48120
- Applicant
- Dlp, Inc.
Grand Rapids, MI, US - Received
- October 17, 1991
- Decision date
- January 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K953945 | Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer…DWF · Traditional | 03/26/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | 04/25/1995SE |
| K934215 | Contain-OrKKX · Traditional | 02/09/1994SE |
| K915268 | Catheter Two Stage Venous ReturnDWF · Traditional | 07/27/1992SE |
| K913077 | Lancaster Cooling Jacket, Cat. Code #13500/13501DTR · Traditional | 01/09/1992SE |
| K913098 | Apiration Biopsy Syringe Gun, Cat. Code #54501KNW · Traditional | 11/05/1991SE |
| K912229 | Ima Electrocautery Electrode Cat. #60002/60003GEI · Traditional | 09/25/1991SE |
| K904172 | Accuplace (TM)GDF · Traditional | 11/21/1990SE |
Questions and answers
When was Breast Les Local Wire St. 48219/49220/48119/48120 cleared by the FDA?
Breast Les Local Wire St. 48219/49220/48119/48120 (K914608) received a 510(k) decision of Substantially Equivalent on January 9, 1992, 84 days after the submission was received.
What is the product code of K914608?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.