The following data is part of a premarket notification filed by Gebauer Co. with the FDA for Gebauer's Skin Refrigerant (mist Spray), Model P/n 0386-0010-07, Gebauer's Skin Refrigerent (medium Spray), Model P/n-03.
| Device ID | K031036 |
| 510k Number | K031036 |
| Device Name: | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland, OH 44104 |
| Contact | Amy J Paukovits |
| Correspondent | Amy J Paukovits 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 | 2003-04-01 |
| Decision Date | 2003-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20303860004046 | K031036 | 000 |