Eye Tray
FDA 510(k) K912105 · Medical Device Inspection Co., Inc.
510(k) numberK912105
Submission
- Device name
- Eye Tray
- Applicant
- Medical Device Inspection Co., Inc.
Great Neck, NY, US - Received
- May 13, 1991
- Decision date
- August 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRP – Tray, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LRP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963723 | Laceration TrayLRP · Traditional | Grand Medical Products | 11/27/1996SE |
| K951811 | Osteotech Musculoskeletal Tissue Recovery PackLRP · Traditional | Osteotech, Inc. | 05/31/1995SE |
| K940239 | Eye TrayLRP · Traditional | Cush Medical Products | 06/28/1994SEKD |
| 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 |
| 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 |
| K905462 | Procedure Tray/For Various Ophthalmic ProceduresLRP · Traditional | Angiosystems, Inc. | 02/06/1991SE |
More from Angiosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945826 | J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software…HCC · Traditional | 08/04/1995SE |
| K932072 | Jarit Surgical InstrumentsHET · Traditional | 01/11/1994SE |
| K931594 | Thera-Turn CM-1000 Mattress Overlay SystemIOQ · Traditional | 12/21/1993SE |
| K933581 | Powermatic Treatment TableINQ · Traditional | 11/05/1993SE |
| K933580 | Power Work TableINQ · Traditional | 11/05/1993SE |
| K933578 | Powermatic Mat PlatformINQ · Traditional | 11/05/1993SE |
| K933577 | Powermatic Examination TableINQ · Traditional | 09/30/1993SE |
| K922045 | Shower ChairsINM · Traditional | 05/26/1992SE |
| K912075 | C-Section TrayKNA · Traditional | 04/07/1992SESK |
| K914174 | Sterile Disposable Wet Skin Scrub TrayLRO · Traditional | 02/24/1992SEKD |
Questions and answers
When was Eye Tray cleared by the FDA?
Eye Tray (K912105) received a 510(k) decision of Substantially Equivalent on August 29, 1991, 108 days after the submission was received.
What is the product code of K912105?
The FDA product code is LRP – Tray, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.