The following data is part of a premarket notification filed by Rand S.r.l. with the FDA for Hang&go Pac.
| Device ID | K161613 |
| 510k Number | K161613 |
| Device Name: | Hang&Go PAC |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | RanD S.r.l. via Statale 12, 62 Medolla, IT 41036 |
| Contact | Simone Ceretti |
| Correspondent | Simone Ceretti RanD S.r.l. via Statale 12, 62 Medolla, IT 41036 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-10 |
| Decision Date | 2016-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M640R99001170001 | K161613 | 000 |
| M640R99001170011 | K161613 | 000 |
| M640R99001170021 | K161613 | 000 |
| M640R99001170031 | K161613 | 000 |