Cement Spacers
FDA 510(k) K791351 · Depuy, Inc.
510(k) numberK791351
Submission
- Device name
- Cement Spacers
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- July 17, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYB – Lens, Guide, Intraocular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Specialty
- Ophthalmic
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| K001157 | Monarch II Iol Delivery SystemKYB · Traditional | Alcon Research, Ltd. | 06/27/2000SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | Staar Surgical Co. | 12/04/1998SE |
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Questions and answers
When was Cement Spacers cleared by the FDA?
Cement Spacers (K791351) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 17 days after the submission was received.
What is the product code of K791351?
The FDA product code is KYB – Lens, Guide, Intraocular, a Class I (low risk) device regulated under 21 CFR 886.4300.