The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio Thoracic Collection Unit.
Device ID | K801942 |
510k Number | K801942 |
Device Name: | OHIO THORACIC COLLECTION UNIT |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-13 |
Decision Date | 1980-09-16 |