Device Classification Name |
Syringe, Antistick
|
510(k) Number |
K012121 |
Device Name |
SECUREGUARD RETRACTABLE SAFETY SYRINGE |
Applicant |
SAFEGARD MEDICAL PRODUCTS, INC. |
14802 HADLEIGH WAY |
TAMPA,
FL
33624
|
|
Applicant Contact |
MIKE DAYTON |
Correspondent |
SAFEGARD MEDICAL PRODUCTS, INC. |
14802 HADLEIGH WAY |
TAMPA,
FL
33624
|
|
Correspondent Contact |
MIKE DAYTON |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 07/06/2001 |
Decision Date | 10/24/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|