The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Tuohy Epidural Needle.
| Device ID | K030562 |
| 510k Number | K030562 |
| Device Name: | TUOHY EPIDURAL 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 | 2003-02-21 |
| Decision Date | 2003-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788021684 | K030562 | 000 |
| 10818788023350 | K030562 | 000 |
| 10818788023343 | K030562 | 000 |
| 10818788023336 | K030562 | 000 |
| 10818788023329 | K030562 | 000 |
| 10818788023312 | K030562 | 000 |
| 10818788023305 | K030562 | 000 |
| 10818788023299 | K030562 | 000 |
| 10818788023282 | K030562 | 000 |
| 10818788023275 | K030562 | 000 |
| 10818788023596 | K030562 | 000 |
| 10818788020540 | K030562 | 000 |
| 10818788021509 | K030562 | 000 |
| 10818788023367 | K030562 | 000 |
| 10818788023374 | K030562 | 000 |
| 10818788021677 | K030562 | 000 |
| 10818788021660 | K030562 | 000 |
| 10818788020854 | K030562 | 000 |
| 10818788020847 | K030562 | 000 |
| 10818788020830 | K030562 | 000 |
| 10818788020823 | K030562 | 000 |
| 10818788020816 | K030562 | 000 |
| 10818788020809 | K030562 | 000 |
| 10818788020793 | K030562 | 000 |
| 10818788020786 | K030562 | 000 |
| 10818788023398 | K030562 | 000 |
| 10818788023381 | K030562 | 000 |
| 10818788021486 | K030562 | 000 |