Device Classification Name |
conformer, ophthalmic, biological tissue
|
510(k) Number |
K032104 |
FOIA Releasable 510(k) |
K032104
|
Device Name |
AMNIOLENS |
Applicant |
BIO-TISSUE, INC. |
1301 K STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
DAVID J BLOCH |
Correspondent |
BIO-TISSUE, INC. |
1301 K STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
DAVID J BLOCH |
Regulation Number | 886.3130
|
Classification Product Code |
|
Date Received | 07/08/2003 |
Decision Date | 12/12/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|