Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010
FDA 510(k) K011115 · Heinz Kurz GmbH Medizintechnik
510(k) numberK011115
Submission
- Device name
- Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010
- Applicant
- Heinz Kurz GmbH Medizintechnik
Amsterdam, Nh, NL - Received
- April 12, 2001
- Decision date
- May 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MML – Weights, Eyelid, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5700
- Specialty
- Ophthalmic
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
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| K001123 | Kurz Upper Eyelid Implant Sizers, Model 8000 111MML · Traditional | 04/21/2000SE |
| K000127 | Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10MML · Traditional | 04/12/2000SE |
Questions and answers
When was Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010 cleared by the FDA?
Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010 (K011115) received a 510(k) decision of Substantially Equivalent on May 2, 2001, 20 days after the submission was received.
What is the product code of K011115?
The FDA product code is MML – Weights, Eyelid, External, a Class II (moderate risk) device regulated under 21 CFR 886.5700.