The following data is part of a premarket notification filed by Endovations with the FDA for Oral Aspirator.
Device ID | K871315 |
510k Number | K871315 |
Device Name: | ORAL ASPIRATOR |
Classification | Mouthpiece, Saliva Ejector |
Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
Contact | Lifton, Md |
Correspondent | Lifton, Md ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
Product Code | DYN |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-01 |
Decision Date | 1987-04-15 |