SHAVE PREP SET
FDA 510(k) clearance K770795 · decided 1977-07-11
Clearance details
- K-number
- K770795
- Device name
- SHAVE PREP SET
- Applicant
- Lukens Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-02
- Decision date
- 1977-07-11
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.
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 |