AMNIOLENS
FDA 510(k) clearance K032104 · decided 2003-12-12
Clearance details
- K-number
- K032104
- Device name
- AMNIOLENS
- Applicant
- Bio-Tissue, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-08
- Decision date
- 2003-12-12
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- NQB
- Device class
- 2
- Regulation number
- 886.3130
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.