Koi(Tm) Instrument Trays
FDA 510(k) K881095 · CooperVision, Inc.
510(k) numberK881095
Submission
- Device name
- Koi(Tm) Instrument Trays
- Applicant
- CooperVision, Inc.
Bellevue, WA, US - Received
- March 15, 1988
- Decision date
- April 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRP – Tray, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K963723 | Laceration TrayLRP · Traditional | Grand Medical Products | 11/27/1996SE |
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| K935621 | Custom ENT PacksLRP · Traditional | Associated Medical | 03/30/1994SE |
| K940646 | Orthopedic Tray Product LineLRP · Traditional | Cushindu | 03/11/1994SEKD |
| K940444 | General Surgery TrayLRP · Traditional | Cush Medical Products | 03/07/1994SEKD |
| K922126 | Hospital Kit ENT 1125LRP · Traditional | Savoy Medical Supply Co., Inc. | 01/21/1993SE |
| K912105 | Eye TrayLRP · Traditional | Medical Device Inspection Co., Inc. | 08/29/1991SE |
| K903963 | Kits and Trays for One Time Use OnlyLRP · Traditional | Apk Technology | 07/29/1991SEKD |
| K903962 | Instruments for One Time Use/ DisposableLRP · Traditional | Apk Technology | 07/29/1991SEKD |
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Questions and answers
When was Koi(Tm) Instrument Trays cleared by the FDA?
Koi(Tm) Instrument Trays (K881095) received a 510(k) decision of Substantially Equivalent on April 6, 1988, 22 days after the submission was received.
What is the product code of K881095?
The FDA product code is LRP – Tray, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.