The following data is part of a premarket notification filed by Asahi Polyslider Co., Ltd. with the FDA for Onetouch Delica Safety, Hemocue Safety Lancet, Assure Lance And Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie.
| Device ID | K222084 |
| 510k Number | K222084 |
| Device Name: | OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance And Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Applicant | Asahi Polyslider Co., Ltd. 860-2 Misaki Maniwa, JP 719-3226 |
| Contact | Yoshitaka Akagi |
| Correspondent | Stuart R Goldman Emergo By UL 2500 Bee Cave Road Bldg. 1, Suite 300 Austin, TX 78746 |
| Product Code | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-15 |
| Decision Date | 2022-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10015482991309 | K222084 | 000 |
| 10015482991255 | K222084 | 000 |
| 10015482983281 | K222084 | 000 |
| 10015482981218 | K222084 | 000 |
| 10015482980280 | K222084 | 000 |
| 10015482980228 | K222084 | 000 |
| 10015482980181 | K222084 | 000 |
| 10015482980129 | K222084 | 000 |
| 50015482980080 | K222084 | 000 |