510(k) K882878
K882878 is an FDA 510(k) premarket notification submitted by Cdc Products Corp. for the device "ODOR-END EMERGENCY CLEAN UP POWDER". The FDA issued a decision of Substantially Equivalent on December 8, 1988. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Cdc Products Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1988
- Date Received
- July 11, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Ostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type