M3 Microkeratome
by Moria SA
510(k) K032836
M3 Microkeratome is a medical device (FDA Class I; FDA product code HNO, Keratome, Ac-Powered) made by Moria SA, cleared under FDA 510(k) K032836 on 18 Jun 2004, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032836 | Date18 Jun 2004 | StatusActive |
Official records
- FDA 510(k) database K032836
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HNO
- Device class
- Class I
- Regulation
- 21 CFR Part 886.4370
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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