The following data is part of a premarket notification filed by Norelco Consumer Products Co. with the FDA for Norelco Clean Air System Model Cam665.
Device ID | K942686 |
510k Number | K942686 |
Device Name: | NORELCO CLEAN AIR SYSTEM MODEL CAM665 |
Classification | Cleaner, Air, Medical Recirculating |
Applicant | NORELCO CONSUMER PRODUCTS CO. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein NORELCO CONSUMER PRODUCTS CO. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC |
Product Code | FRF |
CFR Regulation Number | 880.5045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-07 |
Decision Date | 1994-10-07 |