The following data is part of a premarket notification filed by Allseasons Environmental Control, Inc. with the FDA for Uv Air Sterilight.
Device ID | K884579 |
510k Number | K884579 |
Device Name: | UV AIR STERILIGHT |
Classification | Purifier, Air, Ultraviolet, Medical |
Applicant | ALLSEASONS ENVIRONMENTAL CONTROL, INC. 331 EXETER ROAD, UNITS 23-25 London, Ontario, CA |
Contact | David Ritchie |
Correspondent | David Ritchie ALLSEASONS ENVIRONMENTAL CONTROL, INC. 331 EXETER ROAD, UNITS 23-25 London, Ontario, CA |
Product Code | FRA |
CFR Regulation Number | 880.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-03 |
Decision Date | 1988-12-12 |