The following data is part of a premarket notification filed by Temp-stik Corp. with the FDA for Temp-stik Model #300.
Device ID | K791558 |
510k Number | K791558 |
Device Name: | TEMP-STIK MODEL #300 |
Classification | Thermometer, Electronic, Clinical |
Applicant | TEMP-STIK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-17 |
Decision Date | 1979-09-12 |