The following data is part of a premarket notification filed by Seamark Technologies with the FDA for Dolomite Rollator.
| Device ID | K921917 |
| 510k Number | K921917 |
| Device Name: | DOLOMITE ROLLATOR |
| Classification | Chair, With Casters |
| Applicant | SEAMARK TECHNOLOGIES 1901 SOUTH OCEAN BLVD. APT. 108 Boca Raton, FL 33432 |
| Contact | John J Lofquist |
| Correspondent | John J Lofquist SEAMARK TECHNOLOGIES 1901 SOUTH OCEAN BLVD. APT. 108 Boca Raton, FL 33432 |
| Product Code | INM |
| CFR Regulation Number | 890.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-23 |
| Decision Date | 1992-05-26 |