The following data is part of a premarket notification filed by Tisport with the FDA for Tilite Yg And Tilite Ygs.
Device ID | K023606 |
510k Number | K023606 |
Device Name: | TILITE YG AND TILITE YGS |
Classification | Wheelchair, Mechanical |
Applicant | TISPORT 1426 EAST THIRD AVE. Kennewick, WA 99337 -9669 |
Contact | Richard S Forman |
Correspondent | Richard S Forman TISPORT 1426 EAST THIRD AVE. Kennewick, WA 99337 -9669 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-28 |
Decision Date | 2002-11-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853316008082 | K023606 | 000 |