The following data is part of a premarket notification filed by Ttbio Corp. with the FDA for Electric Handpiece System.
| Device ID | K132570 |
| 510k Number | K132570 |
| Device Name: | ELECTRIC HANDPIECE SYSTEM |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | TTBIO CORP. 2F, NO.7, 6TH ROAD INDUSTRY PARK Taichung, Roc, TW 40755 |
| Contact | Shu-ching Lee |
| Correspondent | Shu-ching Lee TTBIO CORP. 2F, NO.7, 6TH ROAD INDUSTRY PARK Taichung, Roc, TW 40755 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-15 |
| Decision Date | 2014-04-29 |
| Summary: | summary |