FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
K Number: K150428
·
Decision Apr 16, 2015
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
35
Applicant Total
29
Review Days
56
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Basic Information
- Device Name
- Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
- K Number
- K150428
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4840
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra Lifesciences Corp.
- Date Received
- February 19, 2015
- Decision Date
- April 16, 2015
- Product Code
- HAE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAE | Rongeur, Manual | FDA class 2 | Neurology |
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