Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
FDA 510(k) clearance K190161 · decided 2019-05-07
Clearance details
- K-number
- K190161
- Device name
- Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
- Applicant
- Gebauer Company
- Decision
- Substantially Equivalent
- Date received
- 2019-01-30
- Decision date
- 2019-05-07
- Days to decision
- 97 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
No recalls on record reference this clearance.