The following data is part of a premarket notification filed by Thunder Tiger Corp. with the FDA for Tiger 500 Series High Speed Handpieces And Attachments.
| Device ID | K102517 |
| 510k Number | K102517 |
| Device Name: | TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | THUNDER TIGER CORP. NO. 7, 6TH ROAD INDUSTRY PARK Taichung, TW 40755 |
| Contact | Jo Lee |
| Correspondent | Jo Lee THUNDER TIGER CORP. NO. 7, 6TH ROAD INDUSTRY PARK Taichung, TW 40755 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-02 |
| Decision Date | 2011-04-27 |
| Summary: | summary |