TRACE MODEL #'S 840, 841, 842, 845
FDA 510(k) clearance K925145 · decided 1993-05-19
Clearance details
- K-number
- K925145
- Device name
- TRACE MODEL #'S 840, 841, 842, 845
- Applicant
- Trace Medical Equipment, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-13
- Decision date
- 1993-05-19
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- FYH
- Device class
- 1
- Regulation number
- 878.3910
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lisle, IL, 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 |
|---|---|---|
| SPECIALIST(R) WALKER (K924984) | Johnson & Johnson Orthopaedics, Inc. | 1993-02-01 |
| KUT-SHIELD (K895092) | Kut-Guard, Inc. | 1989-09-26 |
| SPLINTS(ALL TYPE) (K852558) | The Huxley Instrument Corp. | 1985-07-02 |
| HYDRO-SPLINT A SPONGE-COMPRESS DRESS (K843400) | Compression Splint Products, Inc. | 1984-10-24 |
| J & J DIP WATER ADDITIVE (K821693) | Johnson & Johnson Professionals, Inc. | 1982-07-02 |
| DELTA-LITE CASTING TAPE & SPLINTS (K802522) | Johnson & Johnson Professionals, Inc. | 1981-01-08 |
| ORTHOPEDIC LOWER EXTREMITY SUSPENSION (K801436) | Orthopedic Systems, Inc. | 1980-06-26 |
Recalls involving this device
No recalls on record reference this clearance.