AOD4000 Disposable Pak
FDA 510(k) K931357 · American Optical Corp.
510(k) numberK931357
Submission
- Device name
- AOD4000 Disposable Pak
- Applicant
- American Optical Corp.
Irvine, CA, US - Received
- March 17, 1993
- Decision date
- January 25, 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 |
|---|---|---|
| K950881 | Phaco TipHQC · Traditional | 09/06/1995SE |
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| K931358 | AORP4000 Reusable PakHQC · Traditional | 02/22/1994SE |
| K931354 | P4000 PhacoemulsifierHQC · Traditional | 02/22/1994SE |
| K820790 | Flexible Proctosigmoidoscope, #FPS-3FAM · Traditional | 04/01/1982SE |
| K813430 | Tissue Processing Cassettes & AccessIDL · Traditional | 12/29/1981SE |
| K812965 | Model SC-6, Flexible SiamoidoscopeFAM · Traditional | 11/02/1981SE |
| K812051 | Photolite Aolite Tintomatic LensHQG · Traditional | 09/08/1981SE |
| K812063 | SR-1V Data PrinterHKO · Traditional | 08/18/1981SE |
| K811535 | Model FUS-1, Flexible UreteroscopeFGB · Traditional | 06/23/1981SE |
Questions and answers
When was AOD4000 Disposable Pak cleared by the FDA?
AOD4000 Disposable Pak (K931357) received a 510(k) decision of Substantially Equivalent on January 25, 1994, 314 days after the submission was received.
What is the product code of K931357?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.