Device Classification Name |
Tray, Surgical, Instrument
|
510(k) Number |
K871924 |
Device Name |
STERILIZATION TRAY, TMJ INSTRUMENT SET |
Applicant |
ARTHROPEDICS, INC. |
111 LESTER ST. |
WALLINGTON,
NJ
07057
|
|
Applicant Contact |
HERBERT SCHAINHOLZ |
Correspondent |
ARTHROPEDICS, INC. |
111 LESTER ST. |
WALLINGTON,
NJ
07057
|
|
Correspondent Contact |
HERBERT SCHAINHOLZ |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 05/18/1987 |
Decision Date | 06/01/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|