Device Classification Name |
surgeon's gloves
|
510(k) Number |
K042567 |
Device Name |
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E |
Applicant |
PT. MEDISAFE TECHNOLOGIES |
JL.BATANG KUIS GG.TAMBAK REJO |
DESA BUNTU BEDIMBAR TJ. MORAWA |
MEDAN, NORTH SUMATERA,
ID
20362
|
|
Applicant Contact |
ANIL TANEJA |
Correspondent |
PT. MEDISAFE TECHNOLOGIES |
JL.BATANG KUIS GG.TAMBAK REJO |
DESA BUNTU BEDIMBAR TJ. MORAWA |
MEDAN, NORTH SUMATERA,
ID
20362
|
|
Correspondent Contact |
ANIL TANEJA |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 09/21/2004 |
Decision Date | 01/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|