美国FDA官网搜蓝光英诺REVOTEK的返回结果为:
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申请的是生物胶，按510章申请
510(k) Premarket Notification
2017-09-25 | www.accessdata.fda.gov/s/cdrh/cfdocs/cfpmn/pmn.cfm?id=k012542
... New Search, Back To Search Results. Device Classification Name, sealant, pit and fissure, and conditioner. 510(k) Number, K012542. Device Name, REVOTEK LC. Applicant, GC AMERICA, INC. 3737 west 127th st. ...
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510(k) Premarket Notification
2017-09-25 | www.accessdata.fda.gov/s/cdrh/cfdocs/cfpmn/pmn.cfm?id=k012542
... New Search, Back To Search Results. Device Classification Name, sealant, pit and fissure, and conditioner. 510(k) Number, K012542. Device Name, REVOTEK LC. Applicant, GC AMERICA, INC. 3737 west 127th st. ...
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