FDA 510(k) Applications for Medical Device:
Refrigerant, Topical (Vapocoolant)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K202782 | 623 Medical, LLC |
623 Davis Drive, Suite 100 | Morrisville | NC | 27522 |
| K033720 | ARI |
1733 CANTON LN. | MARIETTA | GA | 30062-2679 |
| K030281 | CRYONIC MEDICAL NORTH AMERICA |
1350 DANIELSON RD. | MONTECITO | CA | 93108 |
| K203661 | CryoScience North America, Inc. |
401 Louisuana St, 8th Floor | Houston | TX | 77002-1629 |
| K984564 | DUKAL CORP. |
3234 ELLA LN. | NEW PORT RICHE | FL | 34655 |
| K991514 | GEBAUER CO. |
9410 ST. CATHERINE AVE. | CLEVELAND | OH | 44104 |
| K001624 | GEBAUER CO. |
9410 ST. CATHERINE AVE. | CLEVELAND | OH | 44104 |
| K002596 | GEBAUER CO. |
9410 ST. CATHERINE AVE. | CLEVELAND | OH | 44104 |
| K021726 | GEBAUER CO. |
9410 ST. CATHERINE AVE. | CLEVELAND | OH | 44104 |
| K031036 | GEBAUER CO. |
9410 ST. CATHERINE AVE. | CLEVELAND | OH | 44104 |
| K032671 | GEBAUER CO. |
9410 ST. CATHERINE AVE. | CLEVELAND | OH | 44104 |
| K190161 | Gebauer Company |
4444 East 153rd Street | Cleveland | OH | 44128 |
| K172028 | Gebauer Company |
4444 East 153rd Street | Cleveland | OH | 44128 |
| K172598 | ITW Contamination Control Electronics |
8125 Cobb Center Drive | Kennesaw | GA | 30152 |
| K172203 | Nuance Medical, LLC |
5931 Sea Lion Place, Suite 113 | Carlsbad | CA | 92010 |
| K162218 | NUANCE MEDICAL, LLC |
5931 Sea Lion Place, Suite 113 | Carlsbad | CA | 92008 |
| K093951 | OCCAM DESIGN |
1044 EAST CHESTNUT ST. | LOUISVILLE | KY | 40204 |
| K992286 | RHEALM PHARMACEUTICALS, INC. |
258 SE 6TH AVE., SUITE 12 | DELRAY BEACH | FL | 33483 |
| K201248 | Vapocoolshot, Inc. |
1155 Main Street, suite 105 | Jupiter | FL | 33458 |
| K193349 | Vapocoolshot, Inc. |
1155 Main Street, Suite 105 | Jupiter | FL | 33458 |
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