Device Classification Name |
Syringe, Piston
|
510(k) Number |
K062702 |
Device Name |
ULTICARE DISPOSABLE SYRINGES AND NEEDLES |
Applicant |
ULTIMED, INC. |
5353 WAYZATA BLVD. |
SUITE 505 |
MINNEAPOLIS,
MN
55416 -1334
|
|
Applicant Contact |
CAROLE STAMP |
Correspondent |
ULTIMED, INC. |
5353 WAYZATA BLVD. |
SUITE 505 |
MINNEAPOLIS,
MN
55416 -1334
|
|
Correspondent Contact |
CAROLE STAMP |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/11/2006 |
Decision Date | 11/29/2006 |
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
|
|
|