510(k) K922401
K922401 is an FDA 510(k) premarket notification submitted by Boston Pacific Medical, Inc. for the device "4 SURE TM COLOSTOMY POUCH". The FDA issued a decision of Substantially Equivalent on June 10, 1992. The device falls under product code EZQ (Pouch, Colostomy), a Class I device regulated under 21 CFR 876.5900. Boston Pacific Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 1992
- Date Received
- May 21, 1992
- 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