The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio Waste Gas Scavenging Reservoir.
Device ID | K841733 |
510k Number | K841733 |
Device Name: | OHIO WASTE GAS SCAVENGING RESERVOIR |
Classification | Apparatus, Gas-scavenging |
Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBN |
CFR Regulation Number | 868.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-26 |
Decision Date | 1984-07-11 |