The following data is part of a premarket notification filed by Pikdare Spa with the FDA for Dropsafetm Sicuratm.
| Device ID | K223353 |
| 510k Number | K223353 |
| Device Name: | DropSafeTM SicuraTM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Pikdare SpA Via Saldarini Catelli 10 Casnate Con Bernate, IT 22070 |
| Contact | Roberta Zanoni |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-11-02 |
| Decision Date | 2022-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20812383030970 | K223353 | 000 |
| 20812383030864 | K223353 | 000 |
| 20812383030871 | K223353 | 000 |
| 20812383030888 | K223353 | 000 |
| 20812383030987 | K223353 | 000 |
| 20812383030994 | K223353 | 000 |
| 20812383031007 | K223353 | 000 |
| 20812383031014 | K223353 | 000 |
| 20812383030901 | K223353 | 000 |
| 20812383030918 | K223353 | 000 |
| 20812383030925 | K223353 | 000 |
| 20812383030932 | K223353 | 000 |
| 20812383030949 | K223353 | 000 |
| 20812383030956 | K223353 | 000 |
| 20812383030963 | K223353 | 000 |
| 20812383030857 | K223353 | 000 |