510(k) K911918
K911918 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "SWIVEL HORSESHOE HEADREST". The FDA issued a decision of Substantially Equivalent on July 17, 1991. The device falls under product code HBM (Headrest, Neurosurgical), a Class I device regulated under 21 CFR 882.4440. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1991
- Date Received
- April 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Headrest, Neurosurgical
- Device Class
- Class I
- Regulation Number
- 882.4440
- Review Panel
- NE
- Submission Type