| 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
|
|
|