JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
FDA 510(k) clearance K092227 · decided 2010-02-17
Clearance details
- K-number
- K092227
- Device name
- JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-23
- Decision date
- 2010-02-17
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- HAE
- Device class
- 2
- Regulation number
- 882.4840
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.