FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K Number: K133921
·
Decision Aug 22, 2014
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
3
Review Days
242
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Basic Information
- Device Name
- PRECEPTIS TYMPANOSTOMY TUBE INSERTER
- K Number
- K133921
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Preceptis Medical
- Date Received
- December 23, 2013
- Decision Date
- August 22, 2014
- Product Code
- ETD
- 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 |
|---|---|---|---|
| ETD | Tube, Tympanostomy | FDA class 2 | Ear, Nose, Throat |
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