The following data is part of a premarket notification filed by Sc Hennig Enterprises Europe Srl with the FDA for O'neil Sterile Field Intermittent Urinary Catheter.
| Device ID | K993651 |
| 510k Number | K993651 |
| Device Name: | O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER |
| Classification | Catheter, Urethral |
| Applicant | SC HENNIG ENTERPRISES EUROPE SRL 25 SHANN ST. FLOREAT PARK Western Australia, AU 6014 |
| Contact | George O'neil |
| Correspondent | George O'neil SC HENNIG ENTERPRISES EUROPE SRL 25 SHANN ST. FLOREAT PARK Western Australia, AU 6014 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-29 |
| Decision Date | 1999-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09350902001256 | K993651 | 000 |
| 09350902001232 | K993651 | 000 |
| 09350902001218 | K993651 | 000 |
| 09350902001195 | K993651 | 000 |
| 09350902001164 | K993651 | 000 |
| 09350902001157 | K993651 | 000 |