Site Sterilization Trays for Ophthalmic Use
FDA 510(k) K883098 · Site Microsurgical Systems, Inc.
510(k) numberK883098
Submission
- Device name
- Site Sterilization Trays for Ophthalmic Use
- Applicant
- Site Microsurgical Systems, Inc.
Horsham, PA, US - Received
- July 22, 1988
- Decision date
- August 18, 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
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 |
|---|---|---|
| K925828 | Modified Site TXR SystemsHQC · Traditional | 02/16/1994SE |
| K925921 | Modified Site Disposable Diaphragm CassetteKYG · Traditional | 12/06/1993SE |
| K931866 | Site's CD II Phacoemulsification HandpieceHQC · Traditional | 11/12/1993SE |
| K921135 | Iolab Power I.V. PoleHQC · Traditional | 06/03/1992SE |
| K920582 | 180 Tip, 1/A Handpiece .3MM End Opening for Opht.HQE · Traditional | 05/08/1992SE |
| K912902 | Phacoemulsification System for Ophthalmic UseHQC · Traditional | 12/17/1991SE |
| K912739 | Site 90 Tip, I/A Handpiece .3MM Side Open/Opth UseHQC · Traditional | 08/28/1991SE |
| K910980 | Site 20 Gauge Reusable Fiber Optic CableHJO · Traditional | 05/22/1991SE |
| K905620 | Modified Site Peristaltic FootswitchEBW · Traditional | 02/27/1991SE |
| K904183 | Site Phacoemulsification HandpieceHQC · Traditional | 12/05/1990SE |
Questions and answers
When was Site Sterilization Trays for Ophthalmic Use cleared by the FDA?
Site Sterilization Trays for Ophthalmic Use (K883098) received a 510(k) decision of Substantially Equivalent on August 18, 1988, 27 days after the submission was received.
What is the product code of K883098?
The FDA product code is LRP – Tray, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.