510(k) K032104
- Device
- AMNIOLENS
- Applicant
- BIO-TISSUE, INC.
- 510(k) number
- K032104
- Product code
- NQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-12
- Date received
- 2003-07-08
- Regulation
- 886.3130
- Classification name
- Conformer, Ophthalmic, Biological Tissue
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID J BLOCH
- Address
- 1301 K St., NW Washington DC US 20005 20005
FDA Registration Numbers#
- 3004802740
- 3042228518
- 3010097171
Source Documents#
Legacy Summary#
summary
FDA Review#
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