MANUFACTURING PROCESS CHANGE
FDA 510(k) clearance K811441 · decided 1981-09-16
Clearance details
- K-number
- K811441
- Device name
- MANUFACTURING PROCESS CHANGE
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-22
- Decision date
- 1981-09-16
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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 |
|---|---|---|
| STRKYER KNEE AUGMENTATION GRAFT (P850054) | Meadox Medicals, Div. Boston Scientific Corp. | 1988-12-30 |