The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Versa-kath Epidural Catheter, Model 156-2124.
| Device ID | K023140 |
| 510k Number | K023140 |
| Device Name: | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Contact | Christopher B Lake |
| Correspondent | Christopher B Lake EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-20 |
| Decision Date | 2003-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788021394 | K023140 | 000 |