PODIATRIC MATERIAL
FDA 510(k) clearance K940132 · decided 1994-09-29
Clearance details
- K-number
- K940132
- Device name
- PODIATRIC MATERIAL
- Applicant
- Crown Delta Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-03
- Decision date
- 1994-09-29
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- MNE
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Yorktown Heights, NY, 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 |
|---|---|---|
| PODIATRIC MATERIAL (K780391) | Crown Delta Corp. | 1978-06-14 |
Recalls involving this device
No recalls on record reference this clearance.