SPERM SELECT(TM)
FDA 510(k) clearance K864524 · decided 1987-02-02
Clearance details
- K-number
- K864524
- Device name
- SPERM SELECT(TM)
- Applicant
- Pharmacia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-17
- Decision date
- 1987-02-02
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Piscataway, NJ, 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 |
|---|---|---|
| MODELS 011 & 011B IRIDOCAPSULAR IOLS (P810042) | Pharmacia, Inc. | 1982-12-15 |