Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K220917 |
Device Name |
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler |
Applicant |
GRI-Alleset, Inc. |
4142 Industry Way |
Flowery Branch,
GA
31403 1
|
|
Applicant Contact |
Marty D Paugh |
Correspondent |
Regulatory Resources Group, Inc. |
111 Laurel Ridge Dr |
Alpharetta,
GA
30004
|
|
Correspondent Contact |
Julie Stephens |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 03/30/2022 |
Decision Date | 05/18/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|