Procedure Tray/For Various Ophthalmic Procedures
FDA 510(k) K905462 · Angiosystems, Inc.
510(k) numberK905462
Submission
- Device name
- Procedure Tray/For Various Ophthalmic Procedures
- Applicant
- Angiosystems, Inc.
Great Neck, NY, US - Received
- December 5, 1990
- Decision date
- February 6, 1991
- 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
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 |
| 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 |
More from Apk Technology
| 510(k) | Device | Decision |
|---|---|---|
| K905464 | Medical Procedure Kits/Arterial Blood SamplingCBT · Traditional | 05/31/1991SEKD |
| K905459 | Surgical Procedure Tray/Laparoscopy CholecystectomLRO · Traditional | 04/05/1991SE |
| K905461 | Procedure Kit/Routine Dental ProceduresEKS · Traditional | 03/05/1991SEKD |
| K905466 | Sterile Disposable Surgical Drape/Abdominal DrapeKKX · Traditional | 02/11/1991SE |
| K905465 | Sterile Dispos Surgical Drape/C-Section DrapeKKX · Traditional | 02/11/1991SE |
| K905460 | Sterile Disposable Drape/Ophthalmic SurgeryHMT · Traditional | 02/06/1991SE |
| K905463 | General Medical Procedure Kit/Skin PreparationFOZ · Traditional | 01/22/1991SEKD |
| K864688 | Arnold-King Pressure DressingNAD · Traditional | 01/12/1987SE |
| K843260 | Angiosys Femoral Angiography DrapeKKX · Traditional | 09/21/1984SE |
| K843259 | Angio Sys Fluoroscope Drape · Traditional | 09/21/1984SE |
Questions and answers
When was Procedure Tray/For Various Ophthalmic Procedures cleared by the FDA?
Procedure Tray/For Various Ophthalmic Procedures (K905462) received a 510(k) decision of Substantially Equivalent on February 6, 1991, 63 days after the submission was received.
What is the product code of K905462?
The FDA product code is LRP – Tray, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.