510(k) K955609
K955609 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "CONVEEN URINE BAG - STERILE". The FDA issued a decision of Substantially Equivalent on December 29, 1995. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), a Class I device regulated under 21 CFR 876.5250. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1995
- Date Received
- December 8, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Urine Collection, Leg, For External Use, Sterile
- Device Class
- Class I
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type