Device Classification Name |
dressing, wound, occlusive
|
510(k) Number |
K102403 |
Device Name |
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL |
Applicant |
SAM MEDICAL PRODUCTS |
27350 SW 95th Ave Ste 3038 Bldg 30 |
Wilsonville,
OR
97070
|
|
Applicant Contact |
JACK N MCCUTCHEON |
Correspondent |
SAM MEDICAL PRODUCTS |
27350 SW 95th Ave Ste 3038 Bldg 30 |
Wilsonville,
OR
97070
|
|
Correspondent Contact |
JACK N MCCUTCHEON |
Regulation Number | 878.4020
|
Classification Product Code |
|
Date Received | 08/24/2010 |
Decision Date | 03/03/2011 |
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
|
Recalls |
CDRH Recalls
|