Hospital Kit ENT 1125
FDA 510(k) K922126 · Savoy Medical Supply Co., Inc.
510(k) numberK922126
Submission
- Device name
- Hospital Kit ENT 1125
- Applicant
- Savoy Medical Supply Co., Inc.
Valley Stream, NY, US - Received
- May 6, 1992
- Decision date
- January 21, 1993
- 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 |
| 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 |
| K905462 | Procedure Tray/For Various Ophthalmic ProceduresLRP · Traditional | Angiosystems, Inc. | 02/06/1991SE |
More from Angiosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922133 | Hospital Kit SV 105LRO · Traditional | 06/07/1993SESK |
| K922130 | Hospital Kit DK 117MDM · Traditional | 05/24/1993SEKD |
| K922127 | Hospital Kit GP 103MDM · Traditional | 03/29/1993SESD |
| K923281 | SV 100200 - Single Use Only - Sterile Hospital KitMDM · Traditional | 03/26/1993SE |
| K922128 | Hospital Kit Ep 104MDM · Traditional | 03/23/1993SESK |
| K923283 | Sup 5415 Single Use Only Sterile Hospital KitKKX · Traditional | 01/04/1993SESK |
Questions and answers
When was Hospital Kit ENT 1125 cleared by the FDA?
Hospital Kit ENT 1125 (K922126) received a 510(k) decision of Substantially Equivalent on January 21, 1993, 260 days after the submission was received.
What is the product code of K922126?
The FDA product code is LRP – Tray, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.