510(k) K890310
K890310 is an FDA 510(k) premarket notification submitted by Kosan Far East Ent. , Ltd. for the device "STERILE FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on November 30, 1989. The device falls under product code EYC (Catheter, Upper Urinary Tract), a Class II device regulated under 21 CFR 876.5130. Kosan Far East Ent. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1989
- Date Received
- January 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Upper Urinary Tract
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type