The following data is part of a premarket notification filed by Teknar, Inc. with the FDA for Iv Stand.
Device ID | K830474 |
510k Number | K830474 |
Device Name: | IV STAND |
Classification | Unit, Phacofragmentation |
Applicant | TEKNAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-15 |
Decision Date | 1983-04-05 |