The following data is part of a premarket notification filed by Gri-alleset, Inc. with the FDA for Gentleheel Micro-preemie, Gentleheel Preemie, Gentleheel Newborn, Gentleheel Toddler.
| Device ID | K220917 |
| 510k Number | K220917 |
| Device Name: | Gentleheel Micro-Preemie, Gentleheel Preemie, Gentleheel Newborn, Gentleheel Toddler |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Applicant | GRI-Alleset, Inc. 4142 Industry Way Flowery Branch, GA 31403 1 |
| Contact | Marty D Paugh |
| Correspondent | Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, GA 30004 |
| Product Code | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-30 |
| Decision Date | 2022-05-18 |