AESCULAP PEEK CRANIOFIX— 510(k) K091692
Substantially EquivalentAesculap, Inc.
FDA 510(k) clearance K091692 for AESCULAP PEEK CRANIOFIX, Substantially Equivalent on 2010-08-12. Applicant: Aesculap, Inc.. Device class: 2.
Clearance details
- Applicant
- Aesculap, Inc.
- Product code
- Code GXR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
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