TRAY, IRRIGATION, STERILE, BASIC
FDA 510(k) clearance K770799 · decided 1977-06-22
Clearance details
- K-number
- K770799
- Device name
- TRAY, IRRIGATION, STERILE, BASIC
- Applicant
- Lukens Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-02
- Decision date
- 1977-06-22
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- 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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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SILK SUTURES (N80989/S005) | Lukens Corp. | 1989-08-01 |
| SILK SUTURES (N80989/S004) | Lukens Corp. | 1988-10-07 |
| SILK SUTURES (N80989/S003) | Lukens Corp. | 1988-03-16 |
| SILK SUTURES (N80989/S001) | Lukens Corp. | 1987-04-24 |