| Device Classification Name |
Pad, Alcohol, Device Disinfectant
|
| 510(k) Number |
K892193 |
| Device Name |
QUICKPAD (ALCOHOL SWABS) |
| Applicant |
| Holtsch Co., Inc. |
| Rural Rte. 3 Box 94 |
|
Califon,
NJ
07830
|
|
| Applicant Contact |
C SCHEYTT |
| Correspondent |
| Holtsch Co., Inc. |
| Rural Rte. 3 Box 94 |
|
Califon,
NJ
07830
|
|
| Correspondent Contact |
C SCHEYTT |
| Classification Product Code |
|
| Date Received | 04/05/1989 |
| Decision Date | 08/04/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|