The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Stingray Epidural Catheter Connector.
| Device ID | K051171 |
| 510k Number | K051171 |
| Device Name: | STINGRAY EPIDURAL CATHETER CONNECTOR |
| Classification | Anesthesia Conduction Kit |
| Applicant | EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Contact | Christopher Lake |
| Correspondent | Christopher Lake EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-06 |
| Decision Date | 2005-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788022100 | K051171 | 000 |
| 10818788021554 | K051171 | 000 |
| 10818788021547 | K051171 | 000 |
| 10818788021530 | K051171 | 000 |
| 40193489490313 | K051171 | 000 |