| Device Classification Name |
First Aid Kit With Drug
|
| 510(k) Number |
K895767 |
| Device Name |
ORIGINAL TICK KIT/1ST AID KIT |
| Applicant |
| Tick Kit, Inc. |
| 164 Waterhole Rd. |
|
East Hampton,
NY
11937
|
|
| Applicant Contact |
FRANK BICKLEY |
| Correspondent |
| Tick Kit, Inc. |
| 164 Waterhole Rd. |
|
East Hampton,
NY
11937
|
|
| Correspondent Contact |
FRANK BICKLEY |
| Classification Product Code |
|
| Date Received | 09/27/1989 |
| Decision Date | 12/22/1989 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|