Device Classification Name |
Pump, Infusion, Elastomeric
|
510(k) Number |
K072921 |
Device Name |
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM |
Applicant |
SYMBIOS MEDICAL PRODUCTS, LLC |
7301 GEORGETOWN RD |
SUITE 150 |
INDIANAPOLIS,
IN
46268 -4194
|
|
Applicant Contact |
JEFFREY ALHOLM |
Correspondent |
SYMBIOS MEDICAL PRODUCTS, LLC |
7301 GEORGETOWN RD |
SUITE 150 |
INDIANAPOLIS,
IN
46268 -4194
|
|
Correspondent Contact |
JEFFREY ALHOLM |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/15/2007 |
Decision Date | 11/26/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|