INSTRUMENTS FOR NEUROLOGICAL SURGERY
FDA 510(k) clearance K901313 · decided 1990-07-23
Clearance details
- K-number
- K901313
- Device name
- INSTRUMENTS FOR NEUROLOGICAL SURGERY
- Applicant
- Von Zeppelin GmbH
- Decision
- Substantially Equivalent
- Date received
- 1990-03-20
- Decision date
- 1990-07-23
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- HAE
- Device class
- 2
- Regulation number
- 882.4840
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Pullach, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.