The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Accutron Pollution Reducer.
Device ID | K790638 |
510k Number | K790638 |
Device Name: | ACCUTRON POLLUTION REDUCER |
Classification | Mask, Gas, Anesthetic |
Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSJ |
CFR Regulation Number | 868.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-30 |
Decision Date | 1979-05-25 |