K828326Substantially Equivalent
Unknown
Lasertek Oy, Mchenry IL / Traditional, Substantially Equivalent
K828326 is the FDA 510(k) clearance record for UNKNOWN, cleared for Lasertek OY on . FDA records list 4 510(k) clearances for Lasertek OY, from to . As of , FDA records show no recalls naming K828326.
Clearance record
- Decision date
- Received
- (38 days to decision)
- Review panel
- Unknown
- Applicant
- Lasertek OY 803 N. Front St. Suite 3, Mchenry IL
- Third party review
- No
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