FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
K Number: K992457
·
Decision Aug 27, 1999
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
3
Review Days
35
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Basic Information
- Device Name
- SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
- K Number
- K992457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Navigation Specialists, Inc.
- Date Received
- July 23, 1999
- Decision Date
- August 27, 1999
- Product Code
- HAW
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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