Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K072542 |
Device Name |
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR |
Applicant |
MEDEGEN MEDICAL MANUFACTURING SYSTEM |
930 WANNAMAKER AVE. |
ONTARIO,
CA
91761
|
|
Applicant Contact |
ALEX MAZZA |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/10/2007 |
Decision Date | 09/25/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|