Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K222681 |
Device Name |
Altaviz Needle Kit |
Applicant |
Altaviz, LLC |
13766 Alton Parkway, Suite 143 |
Irvine,
CA
92618
|
|
Applicant Contact |
James Lescoulie |
Correspondent |
Allied Regulatory Consulting |
1540 Keller Parkway, Suite 108 #170 |
Keller,
TX
76248
|
|
Correspondent Contact |
Sean Griffin |
Regulation Number | 880.5570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/06/2022 |
Decision Date | 12/05/2022 |
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
|
|
|