510(k) K833554
K833554 is an FDA 510(k) premarket notification submitted by Procedure Products, Inc. for the device "MATERIAL ADDITION LEXAN & K-RESIN". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Procedure Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1984
- Date Received
- October 5, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type