Device Classification Name |
Drape, Surgical
|
510(k) Number |
K902031 |
Device Name |
CUSTOMED LAP PACK IV |
Applicant |
CUSTOMED, INC. |
CALLE IGUALDAD #7 |
FAJARDO,
PR
00738
|
|
Applicant Contact |
FELIX B SANTOS |
Correspondent |
CUSTOMED, INC. |
CALLE IGUALDAD #7 |
FAJARDO,
PR
00738
|
|
Correspondent Contact |
FELIX B SANTOS |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 05/04/1990 |
Decision Date | 07/12/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|