510(k) K914530
K914530 is an FDA 510(k) premarket notification submitted by Icn Pharmaceuticals, Inc. for the device "ICAN GT DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on December 18, 1991. The device falls under product code FRQ (Tube, Levine), a Class II device regulated under 21 CFR 876.5980. Icn Pharmaceuticals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1991
- Date Received
- October 11, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Levine
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type