CONCEIVE PLUS
FDA 510(k) clearance K131355 · decided 2013-11-07
Clearance details
- K-number
- K131355
- Device name
- CONCEIVE PLUS
- Applicant
- Sasmar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-10
- Decision date
- 2013-11-07
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- PEB
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.