| Device Classification Name |
Cover, Mattress (Medical Purposes)
|
| 510(k) Number |
K903382 |
| Device Name |
ALLERGY CONTROL COVERS |
| Applicant |
| Allergy Control Products, Inc. |
| 96 Danbury Rd. |
|
Ridgefield,
CT
06877
|
|
| Applicant Contact |
ANNETTE MILLER |
| Correspondent |
| Allergy Control Products, Inc. |
| 96 Danbury Rd. |
|
Ridgefield,
CT
06877
|
|
| Correspondent Contact |
ANNETTE MILLER |
| Regulation Number | 880.6190 |
| Classification Product Code |
|
| Date Received | 07/27/1990 |
| Decision Date | 11/02/1990 |
| 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
|
|
|