The following data is part of a premarket notification filed by Dalton Instrument Corp. with the FDA for Tacamo Manual Wheelchair.
| Device ID | K101719 |
| 510k Number | K101719 |
| Device Name: | TACAMO MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | DALTON INSTRUMENT CORP. 3788 ARAPAHO RD Addiison, TX 75001 |
| Contact | Mei Lein |
| Correspondent | Mei Lein DALTON INSTRUMENT CORP. 3788 ARAPAHO RD Addiison, TX 75001 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-18 |
| Decision Date | 2010-08-25 |
| Summary: | summary |