Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K200397 |
Device Name |
Single Use Biopsy Forceps FB-456D |
Applicant |
Olympus Medical Systems Corp. |
2951 Ishikawa-cho |
Hachioji-shi,
JP
192-8507
|
|
Applicant Contact |
Toshiyuki Nakajima |
Correspondent |
Olympus Coprporation of the Americas |
3500 Corporation Parkway PO Box 610 |
Center Valley,
PA
18034 -0610
|
|
Correspondent Contact |
Jonathan Gilbert |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 02/18/2020 |
Decision Date | 04/24/2020 |
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
|