Device Classification Name |
brush, biopsy, bronchoscope (non-rigid)
|
510(k) Number |
K182927 |
Device Name |
Pulmonary Cytology Brush |
Applicant |
Hobbs Medical, Inc. |
8 Spring Street |
Stafford Springs,
CT
06076
|
|
Applicant Contact |
Carlos O. Acosta |
Correspondent |
Hobbs Medical, Inc. |
8 Spring Street |
Stafford Springs,
CT
06076
|
|
Correspondent Contact |
Carlos O. Acosta |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 10/22/2018 |
Decision Date | 02/07/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|