FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REIGEL TUNNELING DEVICE
K Number: K962761
·
Decision Oct 11, 1996
Classifications
1
FEI Numbers
21
Registration Numbers
22
Same Product Code
12
Applicant Total
190
Review Days
87
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Basic Information
- Device Name
- REIGEL TUNNELING DEVICE
- K Number
- K962761
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4545
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook, Inc.
- Date Received
- July 16, 1996
- Decision Date
- October 11, 1996
- Product Code
- GYK
- 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 |
|---|---|---|---|
| GYK | Instrument, Shunt System Implantation | FDA class 1 | Neurology |
Similar 510(k) Clearances
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HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
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