GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
FDA 510(k) clearance K032671 · decided 2004-03-17
Clearance details
- K-number
- K032671
- Device name
- GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
- Applicant
- Gebauer Co.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-29
- Decision date
- 2004-03-17
- Days to decision
- 201 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 Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (sk recall (Z-1057-2007) | Gebauer Company | 2007-07-23 |
| Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant ( recall (Z-1061-2007) | Gebauer Company | 2007-07-23 |
| Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant (sk recall (Z-1062-2007) | Gebauer Company | 2007-07-23 |