GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
FDA 510(k) clearance K002596 · decided 2001-02-15
Clearance details
- K-number
- K002596
- Device name
- GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
- Applicant
- Gebauer Co.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-21
- Decision date
- 2001-02-15
- Days to decision
- 178 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 Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0 recall (Z-0218-2009) | Gebauer Company | 2008-11-12 |