FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROSURGICAL HEADFRAME ACCESSORIES
K Number: K902517
·
Decision Jul 3, 1990
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
42
Applicant Total
3
Review Days
26
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Basic Information
- Device Name
- NEUROSURGICAL HEADFRAME ACCESSORIES
- K Number
- K902517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Sims Surgical, Inc.
- Date Received
- June 7, 1990
- Decision Date
- July 3, 1990
- Product Code
- GZT
- 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 |
|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | FDA class 2 | Neurology |
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