HEMO-RO
FDA 510(k) clearance K771763 · decided 1977-10-04
Clearance details
- K-number
- K771763
- Device name
- HEMO-RO
- Applicant
- Millipore Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-19
- Decision date
- 1977-10-04
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FIP
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| THERAPEUTIC APHERESIS SYSTEM (P850092) | Millipore Corp. | 1986-11-18 |