The following data is part of a premarket notification filed by Well Lead Medical Co. Ltd with the FDA for Well Lead Pvc Hydrophilic Urethral Catheter.
| Device ID | K133615 |
| 510k Number | K133615 |
| Device Name: | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER |
| Classification | Catheter, Straight |
| Applicant | WELL LEAD MEDICAL CO. LTD 445 APOLLO BEACH BLVD. Apollo Beach, FL 33572 |
| Contact | John Obrien |
| Correspondent | John Obrien WELL LEAD MEDICAL CO. LTD 445 APOLLO BEACH BLVD. Apollo Beach, FL 33572 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-25 |
| Decision Date | 2014-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40888277324603 | K133615 | 000 |
| 40888277324580 | K133615 | 000 |
| 40888277324566 | K133615 | 000 |
| 40888277324542 | K133615 | 000 |
| 40888277324528 | K133615 | 000 |