GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
FDA 510(k) clearance K031036 · decided 2003-07-10
Clearance details
- K-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
- Applicant
- Gebauer Co.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-01
- Decision date
- 2003-07-10
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- MLY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended recall (Z-1058-2007) | Gebauer Company | 2007-07-23 |