The following data is part of a premarket notification filed by Guangdong Baihe Medical Technology Co., Ltd with the FDA for Disposable Silicone Foley Catheter.
| Device ID | K130908 |
| 510k Number | K130908 |
| Device Name: | DISPOSABLE SILICONE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD PO BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD PO BOX 120-119 Shanghai, CN 200120 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-01 |
| Decision Date | 2013-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26938634494941 | K130908 | 000 |
| 26938634494828 | K130908 | 000 |
| 26938634494811 | K130908 | 000 |
| 26938634494804 | K130908 | 000 |
| 26938634494798 | K130908 | 000 |
| 26938634494781 | K130908 | 000 |
| 26938634494774 | K130908 | 000 |
| 26938634494767 | K130908 | 000 |
| 26938634494750 | K130908 | 000 |
| 26938634494835 | K130908 | 000 |
| 26938634494842 | K130908 | 000 |
| 26938634494859 | K130908 | 000 |
| 26938634494934 | K130908 | 000 |
| 26938634494927 | K130908 | 000 |
| 26938634494910 | K130908 | 000 |
| 26938634494903 | K130908 | 000 |
| 26938634494897 | K130908 | 000 |
| 26938634494880 | K130908 | 000 |
| 26938634494873 | K130908 | 000 |
| 26938634494866 | K130908 | 000 |
| 26938634494743 | K130908 | 000 |