EYE TRAY
FDA 510(k) clearance K940239 · decided 1994-06-28
Clearance details
- K-number
- K940239
- Device name
- EYE TRAY
- Applicant
- Cush Medical Products
- Decision
- Unknown
- Date received
- 1994-01-19
- Decision date
- 1994-06-28
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- LRP
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Piney Flats, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LACERATION TRAY (K963723) | Grand Medical Products | 1996-11-27 |
| OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK (K951811) | Osteotech, Inc. | 1995-05-31 |
| CUSTOM ENT PACKS (K935621) | Associated Medical | 1994-03-30 |
| ORTHOPEDIC TRAY PRODUCT LINE (K940646) | Cushindu | 1994-03-11 |
| GENERAL SURGERY TRAY (K940444) | Cush Medical Products | 1994-03-07 |
| HOSPITAL KIT ENT 1125 (K922126) | Savoy Medical Supply Co., Inc. | 1993-01-21 |
| EYE TRAY (K912105) | Medical Device Inspection Co., Inc. | 1991-08-29 |
| KITS AND TRAYS FOR ONE TIME USE ONLY (K903963) | Apk Technology | 1991-07-29 |
| INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (K903962) | Apk Technology | 1991-07-29 |
| PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (K905462) | Angiosystems, Inc. | 1991-02-06 |
| CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS (K903544) | J.J. Skinner, Inc. | 1990-08-31 |
| STERILE LACERATION TRAY (K890071) | Mumtaz I. Malik | 1989-01-24 |
Recalls involving this device
No recalls on record reference this clearance.