The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Ethyl Chloride Dispenser.
Device ID | K984564 |
510k Number | K984564 |
Device Name: | ETHYL CHLORIDE DISPENSER |
Classification | Refrigerant, Topical (vapocoolant) |
Applicant | DUKAL CORP. 3234 ELLA LN. New Port Riche, FL 34655 |
Contact | Ed Rasom |
Correspondent | Ed Rasom DUKAL CORP. 3234 ELLA LN. New Port Riche, FL 34655 |
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 | 1998-12-23 |
Decision Date | 1999-12-02 |
Summary: | summary |