FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BARTON-MAYO TRACHEOSTOMA BUTTON
K Number: K901377
·
Decision Jun 14, 1990
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
3
Applicant Total
1
Review Days
84
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Basic Information
- Device Name
- BARTON-MAYO TRACHEOSTOMA BUTTON
- K Number
- K901377
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Medical Innovations International, Inc.
- Date Received
- March 22, 1990
- Decision Date
- June 14, 1990
- Product Code
- KAC
- 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 |
|---|---|---|---|
| KAC | Tube, Laryngectomy | FDA class 1 | Ear, Nose, Throat |
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