FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
INSTRUMENTS FOR NEUROLOGICAL SURGERY
K Number: K901313
·
Decision Jul 23, 1990
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
35
Applicant Total
5
Review Days
125
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Basic Information
- Device Name
- INSTRUMENTS FOR NEUROLOGICAL SURGERY
- K Number
- K901313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4840
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Von Zeppelin GmbH
- Date Received
- March 20, 1990
- Decision Date
- July 23, 1990
- Product Code
- HAE
- 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 |
|---|---|---|---|
| HAE | Rongeur, Manual | FDA class 2 | Neurology |
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Other Clearances by Von Zeppelin GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K013091 | ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM | Jan 25, 2002 | Substantially Equivalent |
| K954658 | PERNECZKY CLIP APPLIER/REMOVER | Oct 8, 1996 | Substantially Equivalent |
| K903151 | INTERVERTEBRAL DISC RONGEUR | Dec 11, 1990 | Substantially Equivalent |
| K901312 | PERNECZKY ANEURYSM CLIP | Aug 17, 1990 | Substantially Equivalent |