FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUOROFILM(R)
K Number: K933800
·
Decision Jun 24, 1994
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
5
Review Days
324
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Basic Information
- Device Name
- FLUOROFILM(R)
- K Number
- K933800
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Custom Medical, Inc.
- Date Received
- August 4, 1993
- Decision Date
- June 24, 1994
- Product Code
- EMX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
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