The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Mini-shaker.
Device ID | K813318 |
510k Number | K813318 |
Device Name: | MINI-SHAKER |
Classification | Shaker/stirrer |
Applicant | DYNATECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JRQ |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-24 |
Decision Date | 1981-12-17 |