Device Classification Name |
Needle, Acupuncture, Single Use
|
510(k) Number |
K043277 |
Device Name |
C&G ACUPUNCTURE NEEDLE |
Applicant |
HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
ERIC CHENG |
Correspondent |
HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
ERIC CHENG |
Regulation Number | 880.5580
|
Classification Product Code |
|
Date Received | 11/26/2004 |
Decision Date | 02/08/2005 |
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
|
|
|