510(k) K932305
K932305 is an FDA 510(k) premarket notification submitted by Sharn, Inc. for the device "VILA-COOKE(TM) ANESTHESIA PILLOW". The FDA issued a decision of Substantially Equivalent on October 5, 1993. The device falls under product code CCX (Support, Patient Position), a Class I device regulated under 21 CFR 868.6820. Sharn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1993
- Date Received
- May 12, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Patient Position
- Device Class
- Class I
- Regulation Number
- 868.6820
- Review Panel
- AN
- Submission Type