FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE DENVER SPLINT
K Number: K791053
·
Decision Aug 16, 1979
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
14
Applicant Total
1
Review Days
71
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Basic Information
- Device Name
- THE DENVER SPLINT
- K Number
- K791053
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Ronald D. Shippert, M.D.
- Date Received
- June 6, 1979
- Decision Date
- August 16, 1979
- Product Code
- EPP
- 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 |
|---|---|---|---|
| EPP | Splint, Nasal | FDA class 1 | Ear, Nose, Throat |
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