The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Flexible Spinal Needle.
| Device ID | K043467 |
| 510k Number | K043467 |
| Device Name: | FLEXIBLE 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 Lake |
| Correspondent | Christopher 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 | 2004-12-15 |
| Decision Date | 2005-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788021691 | K043467 | 000 |
| 10818788021479 | K043467 | 000 |
| 10818788021462 | K043467 | 000 |
| 10818788021455 | K043467 | 000 |
| 10818788021448 | K043467 | 000 |
| 10818788021387 | K043467 | 000 |