INSTRUMENT TIP PROTECTION COVERS
FDA 510(k) clearance K834127 · decided 1984-02-17
Clearance details
- K-number
- K834127
- Device name
- INSTRUMENT TIP PROTECTION COVERS
- Applicant
- Devon Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-29
- Decision date
- 1984-02-17
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- LXZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, 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 |
|---|---|---|
| GRIP-A-BOOTS (K955463) | Sil-Med Corp. | 1996-01-23 |
Recalls involving this device
No recalls on record reference this clearance.