The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for One-way Air Valve.
Device ID | K840253 |
510k Number | K840253 |
Device Name: | ONE-WAY AIR VALVE |
Classification | Trap, Sterile Specimen |
Applicant | DELTA MEDICAL INDUSTRIES 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 | 1984-01-23 |
Decision Date | 1984-04-05 |