The following data is part of a premarket notification filed by Tumble Forms with the FDA for Tumble Forms Tristander.
| Device ID | K922965 |
| 510k Number | K922965 |
| Device Name: | TUMBLE FORMS TRISTANDER |
| Classification | Table, Mechanical |
| Applicant | TUMBLE FORMS 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook TUMBLE FORMS 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | INW |
| CFR Regulation Number | 890.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-19 |
| Decision Date | 1992-07-13 |