Device Classification Name |
Accessories, Cleaning, For Endoscope
|
510(k) Number |
K933354 |
Device Name |
HOBBS MEDICAL CLEANING BRUSH |
Applicant |
HOBBS MEDICAL, INC. |
497 N. MAIN ST. |
PALMER,
MA
01069
|
|
Applicant Contact |
ROB WHALEN |
Correspondent |
HOBBS MEDICAL, INC. |
497 N. MAIN ST. |
PALMER,
MA
01069
|
|
Correspondent Contact |
ROB WHALEN |
Regulation Number | 876.1500 |
Classification Product Code |
|
Date Received | 07/09/1993 |
Decision Date | 10/28/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|