510(k) K052229
K052229 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "COLOPLAST OSTOMY ROD, MODEL 12814". The FDA issued a decision of Substantially Equivalent on Oct 13, 2006. The device falls under product code EZP (Rod, Colostomy), a Class II device regulated under 21 CFR 876.4270. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 2006
- Date Received
- Aug 16, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Colostomy
- Device Class
- Class II
- Regulation Number
- 876.4270
- Review Panel
- GU
- Submission Type