The following data is part of a premarket notification filed by Itw Contamination Control Electronics with the FDA for Coventry Topical Anesthetic Mist Spray Hazmat Free, Coventry Topical Anesthetic Stream Spray Hazmat Free.
| Device ID | K172598 |
| 510k Number | K172598 |
| Device Name: | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | ITW Contamination Control Electronics 8125 Cobb Center Drive Kennesaw, GA 30152 |
| Contact | Steve Cook |
| Correspondent | Steve Cook ITW Contamination Control Electronics 8125 Cobb Center Drive Kennesaw, GA 30152 |
| 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 | 2017-08-29 |
| Decision Date | 2018-04-19 |
| Summary: | summary |