FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOSEBLEED NOSECLIP
K Number: K981966
·
Decision Aug 14, 1998
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
2
Review Days
71
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Basic Information
- Device Name
- NOSEBLEED NOSECLIP
- K Number
- K981966
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Michael M. Knott, M.D.
- Date Received
- June 4, 1998
- Decision Date
- August 14, 1998
- 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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Other Clearances by Michael M. Knott, M.D.
| K Number | Device Name | ||
|---|---|---|---|
| K971354 | KNOTT NG TUBE | Nov 19, 1997 | Substantially Equivalent |