Standard Phaco Tip 15, 30, 45, 60
FDA 510(k) K940083 · Medical Technical Products
510(k) numberK940083
Submission
- Device name
- Standard Phaco Tip 15, 30, 45, 60
- Applicant
- Medical Technical Products
Laguna Hills, CA, US - Received
- January 7, 1994
- Decision date
- September 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940088 | Medical Technical Products Standard Ultrasonic HandpieceHQC · Traditional | 08/04/1994SE |
| K940084 | Model 2000 Ophthalmic Surgical SystemHQC · Traditional | 06/17/1994SE |
| K910335 | MTP Transport Infusion Pump, Model No. MtpleaFRN · Traditional | 03/13/1991SE |
| K905251 | MTP Transport Infusion Pump Model No. 1001AFRN · Traditional | 02/07/1991SE |
| K904612 | I/A-Phaco System (Irr./Aspir./And Phaco./System)HQC · Traditional | 12/26/1990SE |
| K871474 | Part #860070 Ultrapak & #860075 UltrapakHOC · Traditional | 08/10/1987SE |
| K871473 | Part #860065 Ia Pak & Part #860060 Ia PakHQC · Traditional | 08/10/1987SE |
Questions and answers
When was Standard Phaco Tip 15, 30, 45, 60 cleared by the FDA?
Standard Phaco Tip 15, 30, 45, 60 (K940083) received a 510(k) decision of Substantially Equivalent on September 28, 1994, 264 days after the submission was received.
What is the product code of K940083?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.