The following data is part of a premarket notification filed by Imd Inc with the FDA for Fenestrated Nerve Block Needle.
Device ID | K113662 |
510k Number | K113662 |
Device Name: | FENESTRATED NERVE BLOCK NEEDLE |
Classification | Anesthesia Conduction Kit |
Applicant | IMD INC PO BOX 510 9202 KELLY DRIVE Huntsville, UT 84317 |
Contact | Walter Zohmann |
Correspondent | Walter Zohmann IMD INC PO BOX 510 9202 KELLY DRIVE Huntsville, UT 84317 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-07 |
Decision Date | 2012-04-20 |
Summary: | summary |