510(k) K884577
K884577 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "PROCEDURE READY TRAYS". The FDA issued a decision of Substantially Equivalent (with conditions) on August 1, 1989. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Professional Medical Services has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- August 1, 1989
- Date Received
- November 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type