The following data is part of a premarket notification filed by Dupaco, Inc. with the FDA for Unifilter Anesthesia & Respiratory Filt.
Device ID | K841581 |
510k Number | K841581 |
Device Name: | UNIFILTER ANESTHESIA & RESPIRATORY FILT |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | DUPACO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-17 |
Decision Date | 1984-04-30 |