The following data is part of a premarket notification filed by Bemis Health Care with the FDA for Specimen Adaptor.
Device ID | K822557 |
510k Number | K822557 |
Device Name: | SPECIMEN ADAPTOR |
Classification | Trap, Sterile Specimen |
Applicant | BEMIS HEALTH CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-24 |
Decision Date | 1982-10-18 |