The following data is part of a premarket notification filed by Ari with the FDA for Ari Cold Spray.
| Device ID | K033720 |
| 510k Number | K033720 |
| Device Name: | ARI COLD SPRAY |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | ARI 1733 CANTON LN. Marietta, GA 30062 -2679 |
| Contact | Ron Arkin |
| Correspondent | Ron Arkin ARI 1733 CANTON LN. Marietta, GA 30062 -2679 |
| Product Code | MLY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2005-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50347682030051 | K033720 | 000 |
| 50347682230178 | K033720 | 000 |