FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Precision Thin Reciprocating Blade, 0.010in.
K Number: K161514
·
Decision Jan 17, 2017
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
17
Applicant Total
81
Review Days
229
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Basic Information
- Device Name
- Precision Thin Reciprocating Blade, 0.010in.
- K Number
- K161514
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4140
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- June 2, 2016
- Decision Date
- January 17, 2017
- Product Code
- EQJ
- 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 |
|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | FDA class 1 | Ear, Nose, Throat |
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