510(k) K894032
K894032 is an FDA 510(k) premarket notification submitted by Sharn, Inc. for the device "EVAC-TUBE". The FDA issued a decision of Substantially Equivalent on August 31, 1989. The device falls under product code CAO (Airway, Esophageal (Obturator)), a Class II device regulated under 21 CFR 868.5650. Sharn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1989
- Date Received
- June 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Airway, Esophageal (Obturator)
- Device Class
- Class II
- Regulation Number
- 868.5650
- Review Panel
- AN
- Submission Type