Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K191976 |
Device Name |
Piper GO-IO Intraosseous Infusion System |
Applicant |
Piper Access, LLC |
3981 South 700 East Suite #15 |
Salt Lake City,
UT
84107
|
|
Applicant Contact |
Jacob Lee |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 07/24/2019 |
Decision Date | 11/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|