| Device Classification Name |
Gauze / Sponge,Nonresorbable For External Use
|
| 510(k) Number |
K770410 |
| Device Name |
BANDAGE COMPRESS 2, 3, 4 |
| Applicant |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767 -0350
|
|
| Correspondent |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767 -0350
|
|
| Regulation Number | 878.4014 |
| Classification Product Code |
|
| Date Received | 03/04/1977 |
| Decision Date | 06/09/1977 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|