Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K190715 |
Device Name |
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand |
Applicant |
Interscope, Inc. |
100 Main Street, Suite 108 |
Whitinsville,
MA
01588
|
|
Applicant Contact |
Jeffery Ryan |
Correspondent |
ICON Clinical Research, LLC |
2100 Pennbrook Parkway |
North Wales,
PA
19454
|
|
Correspondent Contact |
Cynthia Nolte |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 03/19/2019 |
Decision Date | 12/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|