The following data is part of a premarket notification filed by Sorensen Research with the FDA for Thoracic Gauge #tg-60 -vacuum Regulator.
Device ID | K831505 |
510k Number | K831505 |
Device Name: | THORACIC GAUGE #TG-60 -VACUUM REGULATOR |
Classification | Regulator, Vacuum |
Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDP |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-11 |
Decision Date | 1983-07-12 |