| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K052720 |
| Device Name |
MEDLINE IODOFORM PACKING STRIPS |
| Applicant |
| Medline Industries, Inc. |
| One Medline Pl. |
|
Mundelein,
IL
60060
|
|
| Applicant Contact |
LARA N SIMMONS |
| Correspondent |
| Medline Industries, Inc. |
| One Medline Pl. |
|
Mundelein,
IL
60060
|
|
| Correspondent Contact |
LARA N SIMMONS |
| Classification Product Code |
|
| Date Received | 09/29/2005 |
| Decision Date | 10/20/2005 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
Yes
|
Predetermined Change Control Plan Authorized |
No
|
|
|