The following data is part of a premarket notification filed by Amd Medicom Inc. with the FDA for Amd Ritmed Assurewear Versagown.
| Device ID | K190306 |
| 510k Number | K190306 |
| Device Name: | AMD Ritmed AssureWear VersaGown |
| Classification | Gown, Isolation, Surgical |
| Applicant | AMD Medicom Inc. 2555 Chemin De L'Aviation Pointe-claire, Montreal, CA H9p 2z2 |
| Contact | Ronald Reuben |
| Correspondent | Nektaria Markoglou AMD Medicom Inc. 2555 Chemin De L'Aviation Pointe-claire, Montreal, CA H9p2z2 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-12 |
| Decision Date | 2020-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20686864051873 | K190306 | 000 |
| 20686864041140 | K190306 | 000 |