The following data is part of a premarket notification filed by Kosan Far East Ent. Ltd. with the FDA for Sterile Foley Catheter.
| Device ID | K890310 |
| 510k Number | K890310 |
| Device Name: | STERILE FOLEY CATHETER |
| Classification | Catheter, Upper Urinary Tract |
| Applicant | KOSAN FAR EAST ENT. LTD. ROOM 1606 SINO CENTRE 582-592 NATHAN ROAD KOWLOON Hong Kong, TW |
| Contact | Shozo Saito |
| Correspondent | Shozo Saito KOSAN FAR EAST ENT. LTD. ROOM 1606 SINO CENTRE 582-592 NATHAN ROAD KOWLOON Hong Kong, TW |
| Product Code | EYC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-11-30 |