510(k) K993062
K993062 is an FDA 510(k) premarket notification submitted by Olson Medical Sales, Inc. for the device "CHEST DRAINAGE TUBING". The FDA issued a decision of Substantially Equivalent on December 10, 1999. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. Olson Medical Sales, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1999
- Date Received
- September 13, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Pump, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4390
- Review Panel
- CV
- Submission Type