FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
K Number: K172028
·
Decision Oct 27, 2017
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
22
Applicant Total
2
Review Days
114
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Basic Information
- Device Name
- Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
- K Number
- K172028
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gebauer Company
- Date Received
- July 5, 2017
- Decision Date
- October 27, 2017
- Product Code
- MLY
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MLY | Vapocoolant Device | FDA unclassified | Unknown |
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Other Clearances by Gebauer Company
| K Number | Device Name | ||
|---|---|---|---|
| K190161 | 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 | May 7, 2019 | Substantially Equivalent |