Device Classification Name |
Syringe, Piston
|
510(k) Number |
K023108 |
Device Name |
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE |
Applicant |
ATLANTIC PRODUCTS, INC. |
24 CENTER ST. |
HICKSVILLE,
NY
11801
|
|
Applicant Contact |
MAHBUBUR RAHMAN |
Correspondent |
ATLANTIC PRODUCTS, INC. |
24 CENTER ST. |
HICKSVILLE,
NY
11801
|
|
Correspondent Contact |
MAHBUBUR RAHMAN |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/18/2002 |
Decision Date | 12/03/2002 |
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
|
|
|