The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Pencil Point Needle.
| Device ID | K041843 |
| 510k Number | K041843 |
| Device Name: | PENCIL POINT NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK Johnstown, NY 12095 |
| Contact | Chris Lake |
| Correspondent | Chris 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 | 2004-07-08 |
| Decision Date | 2004-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788020762 | K041843 | 000 |
| 10818788020502 | K041843 | 000 |
| 10818788020496 | K041843 | 000 |
| 10818788020489 | K041843 | 000 |
| 10818788020472 | K041843 | 000 |
| 10818788020465 | K041843 | 000 |
| 10818788020458 | K041843 | 000 |
| 10818788020441 | K041843 | 000 |
| 10818788020434 | K041843 | 000 |
| 10818788020427 | K041843 | 000 |
| 10818788020519 | K041843 | 000 |
| 10818788020564 | K041843 | 000 |
| 10818788020755 | K041843 | 000 |
| 10818788020748 | K041843 | 000 |
| 10818788020731 | K041843 | 000 |
| 10818788020625 | K041843 | 000 |
| 10818788020618 | K041843 | 000 |
| 10818788020601 | K041843 | 000 |
| 10818788020595 | K041843 | 000 |
| 10818788020588 | K041843 | 000 |
| 10818788020571 | K041843 | 000 |
| 10818788023626 | K041843 | 000 |