FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K
K Number: K971411
·
Decision Jun 3, 1997
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
3
Review Days
48
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Basic Information
- Device Name
- DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K
- K Number
- K971411
- 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
- Bentec Medical, Inc.
- Date Received
- April 16, 1997
- Decision Date
- June 3, 1997
- 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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