| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K852545 |
| Device Name |
BAND-AID BRAND ADHESIVE BANDAGES |
| Applicant |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767
|
|
| Applicant Contact |
OMEGA NORTON-CRABLE |
| Correspondent |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767
|
|
| Correspondent Contact |
OMEGA NORTON-CRABLE |
| Classification Product Code |
|
| Date Received | 06/14/1985 |
| Decision Date | 09/05/1985 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|