SWIVEL HORSESHOE HEADREST
FDA 510(k) clearance K911918 · decided 1991-07-17
Clearance details
- K-number
- K911918
- Device name
- SWIVEL HORSESHOE HEADREST
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-30
- Decision date
- 1991-07-17
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- HBM
- Device class
- 1
- Regulation number
- 882.4440
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Randolph, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CODMAN PEDIATRIC HORSESHOE HEADREST (K911917) | Codman & Shurtleff, Inc. | 1991-07-17 |
| SURGICAL HEAD SUPPORT (K822169) | Kelleher Corp. | 1982-08-20 |
Recalls involving this device
No recalls on record reference this clearance.