The following data is part of a premarket notification filed by International Medical Development, Inc.(imd) with the FDA for Imd's Lumbar Puncture Needle.
| Device ID | K170112 |
| 510k Number | K170112 |
| Device Name: | IMD's Lumbar Puncture Needle |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD) 560 HIGHWAY 39 (PO BOX 510) Huntsville, UT 84317 |
| Contact | Walter Zohmann |
| Correspondent | John E. Lincoln J.E. LINCOLN AND ASSOCIATES PO BOX 2786 St. George, UT 84771 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-12 |
| Decision Date | 2018-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B274GM2250I0 | K170112 | 000 |
| B2742290I0 | K170112 | 000 |
| B2742270I0 | K170112 | 000 |
| B27422190I0 | K170112 | 000 |
| B27422150I0 | K170112 | 000 |
| B27422124I0 | K170112 | 000 |