510(k) K880327
K880327 is an FDA 510(k) premarket notification submitted by Marlen Mfg. & Development Co. for the device "MARLEN ULTRA ILEOSTOMY POUCH-5000". The FDA issued a decision of Substantially Equivalent on February 19, 1988. The device falls under product code EZQ (Pouch, Colostomy), a Class I device regulated under 21 CFR 876.5900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1988
- Date Received
- January 26, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pouch, Colostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type