OUCHLESS MODEL PN10114
FDA 510(k) clearance K093951 · decided 2010-06-15
Clearance details
- K-number
- K093951
- Device name
- OUCHLESS MODEL PN10114
- Applicant
- Occam Design
- Decision
- Substantially Equivalent
- Date received
- 2009-12-23
- Decision date
- 2010-06-15
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- MLY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Louisville, KY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.