MATRIXWAVE MMF SYSTEM
FDA 510(k) clearance K141165 · decided 2014-10-17
Clearance details
- K-number
- K141165
- Device name
- MATRIXWAVE MMF SYSTEM
- Applicant
- Synthes (USA) Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-05-06
- Decision date
- 2014-10-17
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Synthes (USA) Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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.