The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Quincke Spinal Needle.
| Device ID | K022029 |
| 510k Number | K022029 |
| Device Name: | QUINCKE SPINAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| 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 | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-21 |
| Decision Date | 2002-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788020885 | K022029 | 000 |
| 10818788020403 | K022029 | 000 |
| 10818788020397 | K022029 | 000 |
| 10818788020380 | K022029 | 000 |
| 10818788023466 | K022029 | 000 |
| 10818788023459 | K022029 | 000 |
| 10818788023442 | K022029 | 000 |
| 10818788023435 | K022029 | 000 |
| 10818788023428 | K022029 | 000 |
| 10818788023411 | K022029 | 000 |
| 10818788020632 | K022029 | 000 |
| 10818788020649 | K022029 | 000 |
| 10818788020656 | K022029 | 000 |
| 10818788020878 | K022029 | 000 |
| 10818788020861 | K022029 | 000 |
| 10818788020724 | K022029 | 000 |
| 10818788020717 | K022029 | 000 |
| 10818788020700 | K022029 | 000 |
| 10818788020694 | K022029 | 000 |
| 10818788020687 | K022029 | 000 |
| 10818788020670 | K022029 | 000 |
| 10818788020663 | K022029 | 000 |
| 10818788023404 | K022029 | 000 |