FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Strome-Blitzer Cytology Balloon
K Number: K182159
·
Decision Jun 13, 2019
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
29
Applicant Total
1
Review Days
308
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Basic Information
- Device Name
- Strome-Blitzer Cytology Balloon
- K Number
- K182159
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4710
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Adn International, LLC
- Date Received
- August 9, 2018
- Decision Date
- June 13, 2019
- Product Code
- EOX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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