The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Microendoscope.
Device ID | K063078 |
510k Number | K063078 |
Device Name: | MICROENDOSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
Contact | Debbie Cogan |
Correspondent | Debbie Cogan ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-10 |
Decision Date | 2006-10-24 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MICROENDOSCOPE 74521200 not registered Dead/Abandoned |
OPTMED TECHNOLOGIES, INC. 1994-05-04 |