Product code HQS

Device name
Burr, Corneal, Ac-Powered
Medical specialty
Ophthalmic
Device class
1
Regulation number
886.4070
Review panel
OP
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Source
FDA openFDA device classification dataset

Related 510(k) Records

510(k)DeviceApplicantDecision date
K971078HYDROBRUSH (TM) KERATOMEMedjet, Inc.1998-01-23