510(k) K802954
K802954 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "DRESSING CHANGE TRAY-MEDIUM". The FDA issued a decision of Substantially Equivalent on December 17, 1980. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1980
- Date Received
- November 20, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peritoneal Dialysis, Single Use
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type