Device Classification Name |
Arthroscope
|
510(k) Number |
K951843 |
Device Name |
REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT |
Applicant |
FUTURE MEDICAL SYSTEMS, INC. |
205 EAST 63RD ST. |
SUITE 7A |
NEW YORK CITY,
NY
10021
|
|
Applicant Contact |
PATRICK JANIN |
Correspondent |
FUTURE MEDICAL SYSTEMS, INC. |
205 EAST 63RD ST. |
SUITE 7A |
NEW YORK CITY,
NY
10021
|
|
Correspondent Contact |
PATRICK JANIN |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 04/20/1995 |
Decision Date | 07/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|