The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio Absorber.
Device ID | K821144 |
510k Number | K821144 |
Device Name: | OHIO ABSORBER |
Classification | Absorber, Carbon-dioxide |
Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSF |
CFR Regulation Number | 868.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-21 |
Decision Date | 1982-05-28 |