The following data is part of a premarket notification filed by Gebauer Co. with the FDA for Gebauer's Chloride Fine Nozze.
| Device ID | K991514 |
| 510k Number | K991514 |
| Device Name: | GEBAUER'S CHLORIDE FINE NOZZE |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland, OH 44104 |
| Contact | Denise E Spellman |
| Correspondent | Denise E Spellman GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland, OH 44104 |
| 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 | 1999-04-30 |
| Decision Date | 1999-07-16 |
| Summary: | summary |