Extremely Thin 003, ZERO ZERO THREE
FDA 510(k) clearance K192669 · decided 2020-07-24
Clearance details
- K-number
- K192669
- Device name
- Extremely Thin 003, ZERO ZERO THREE
- Applicant
- Okamoto USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-25
- Decision date
- 2020-07-24
- Days to decision
- 303 days
- Clearance type
- Abbreviated
- Product code
- HIS
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Stratford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.