The following data is part of a premarket notification filed by Duracraft Corp. with the FDA for Hepa Air Cleaner.
Device ID | K940573 |
510k Number | K940573 |
Device Name: | HEPA AIR CLEANER |
Classification | Cleaner, Air, Medical Recirculating |
Applicant | DURACRAFT CORP. 355 MAIN ST. Whitinsville, MA 01588 |
Contact | Arthur Wong |
Correspondent | Arthur Wong DURACRAFT CORP. 355 MAIN ST. Whitinsville, MA 01588 |
Product Code | FRF |
CFR Regulation Number | 880.5045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-08 |
Decision Date | 1994-08-25 |