Device Classification Name |
polymer, ent synthetic-polyamide (mesh or foil material)
|
510(k) Number |
K932176 |
Device Name |
BIOSIL MEDICAL GRADE SILICONE SHEETING |
Applicant |
BIOPLEXUS CORP. |
3753 HOWARD HUGHES PKWY. |
SUITE 310 |
LAS VEGAS,
NV
89109
|
|
Applicant Contact |
ESCHBACH |
Correspondent |
BIOPLEXUS CORP. |
3753 HOWARD HUGHES PKWY. |
SUITE 310 |
LAS VEGAS,
NV
89109
|
|
Correspondent Contact |
ESCHBACH |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 05/05/1993 |
Decision Date | 12/02/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|