ORAL ASPIRATOR

Mouthpiece, Saliva Ejector

ENDOVATIONS

The following data is part of a premarket notification filed by Endovations with the FDA for Oral Aspirator.

Pre-market Notification Details

Device IDK871315
510k NumberK871315
Device Name:ORAL ASPIRATOR
ClassificationMouthpiece, Saliva Ejector
Applicant ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill,  PA  17011
ContactLifton, Md
CorrespondentLifton, Md
ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill,  PA  17011
Product CodeDYN  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-01
Decision Date1987-04-15

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