510(k) K132264
K132264 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "PRIMADO2 TOTAL SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on December 17, 2013. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2013
- Date Received
- July 22, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Electric
- Device Class
- Class II
- Regulation Number
- 882.4360
- Review Panel
- NE
- Submission Type