FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILICONE BRAIN SPATULA SET
K Number: K923723
·
Decision Aug 12, 1992
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
33
Applicant Total
1
Review Days
16
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Basic Information
- Device Name
- SILICONE BRAIN SPATULA SET
- K Number
- K923723
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4535
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Redmond Neurosurgical, Inc.
- Date Received
- July 27, 1992
- Decision Date
- August 12, 1992
- Product Code
- HAO
- 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 |
|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | FDA class 1 | Neurology |
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