510(k) K896560
K896560 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "MUCOUS TRAP". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1990
- Date Received
- November 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Suction, Tracheobronchial
- Device Class
- Class I
- Regulation Number
- 868.6810
- Review Panel
- AN
- Submission Type