Device Classification Name |
Cleaner, Air, Medical Recirculating
|
510(k) Number |
K925566 |
Device Name |
HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300 |
Applicant |
HOLMES PRODUCTS CORP. |
233 FORTUNE BLVD. |
GRANITE PARK |
MILFORD,
MA
01757
|
|
Applicant Contact |
NEVILLE R GLENN |
Correspondent |
HOLMES PRODUCTS CORP. |
233 FORTUNE BLVD. |
GRANITE PARK |
MILFORD,
MA
01757
|
|
Correspondent Contact |
NEVILLE R GLENN |
Regulation Number | 880.5045 |
Classification Product Code |
|
Date Received | 11/03/1992 |
Decision Date | 03/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|