AMNIOLENS— 510(k) K032104
Substantially EquivalentBio-Tissue, Inc.
FDA 510(k) clearance K032104 for AMNIOLENS, Substantially Equivalent on 2003-12-12. Applicant: Bio-Tissue, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Tissue, Inc.
- Product code
- Code NQB
- Device class
- Class 2
- Regulation
- 21 CFR 886.3130
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recalls naming K032104
K-number listed on FDA's recall record- Z-0550-2021 — PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
- Z-0551-2021 — PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
- Z-0552-2021 — PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032104.
Data sourced from openFDA. This site is unofficial and independent of the FDA.