FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
K Number: K994191
·
Decision Feb 8, 2000
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
13
Applicant Total
2
Review Days
57
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Basic Information
- Device Name
- SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
- K Number
- K994191
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4175
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nmt Medical, Inc.
- Date Received
- December 13, 1999
- Decision Date
- February 8, 2000
- Product Code
- HCI
- 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 |
|---|---|---|---|
| HCI | Applier, Aneurysm Clip | FDA class 2 | Neurology |
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Other Clearances by Nmt Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K034025 | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC | Mar 26, 2004 | Substantially Equivalent |