The following data is part of a premarket notification filed by Sunbeam-oster Household Products with the FDA for Hepa-type Air Cleaner Model 2586 And True Hepa Air Cleaner Models 2587 And 2588.
Device ID | K960966 |
510k Number | K960966 |
Device Name: | HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 |
Classification | Cleaner, Air, Medical Recirculating |
Applicant | SUNBEAM-OSTER HOUSEHOLD PRODUCTS 95 WL RUNNEL INDUSTRIAL DR. Hattiesburg, MS 39401 |
Contact | David Vanderlin |
Correspondent | David Vanderlin SUNBEAM-OSTER HOUSEHOLD PRODUCTS 95 WL RUNNEL INDUSTRIAL DR. Hattiesburg, MS 39401 |
Product Code | FRF |
CFR Regulation Number | 880.5045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-11 |
Decision Date | 1997-01-10 |