The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Norelco Clean Air System Cas950.
Device ID | K945161 |
510k Number | K945161 |
Device Name: | NORELCO CLEAN AIR SYSTEM CAS950 |
Classification | Cleaner, Air, Medical Recirculating |
Applicant | HOGAN & HARTSON 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein HOGAN & HARTSON 555 THIRTEENTH ST. NW Washington, DC 20004 -1109 |
Product Code | FRF |
CFR Regulation Number | 880.5045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-17 |
Decision Date | 1994-11-28 |