CODMAN SKULL CLAMP
FDA 510(k) clearance K912011 · decided 1991-07-31
Clearance details
- K-number
- K912011
- Device name
- CODMAN SKULL CLAMP
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-06
- Decision date
- 1991-07-31
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HBL
- Device class
- 2
- Regulation number
- 882.4460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Randolph, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.