The following data is part of a premarket notification filed by Bio-tissue, Inc. with the FDA for Amniolens.
| Device ID | K032104 |
| 510k Number | K032104 |
| Device Name: | AMNIOLENS |
| Classification | Conformer, Ophthalmic, Biological Tissue |
| Applicant | BIO-TISSUE, INC. 1301 K STREET, N.W. Washington, DC 20005 |
| Contact | David J Bloch |
| Correspondent | David J Bloch BIO-TISSUE, INC. 1301 K STREET, N.W. Washington, DC 20005 |
| Product Code | NQB |
| CFR Regulation Number | 886.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-08 |
| Decision Date | 2003-12-12 |
| Summary: | summary |