Device Classification Name |
Needle, Acupuncture, Single Use
|
510(k) Number |
K052846 |
Device Name |
TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE |
Applicant |
MAANSHAN MEDICAL INSTRUMENTS CO., LTD. |
13 RED FOX LANE |
LITTLETON,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
MAANSHAN MEDICAL INSTRUMENTS CO., LTD. |
13 RED FOX LANE |
LITTLETON,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 880.5580
|
Classification Product Code |
|
Date Received | 10/07/2005 |
Decision Date | 12/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|