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 |