The following data is part of a premarket notification filed by Mauzer Usa Llc with the FDA for Mauser Pg Ii Sharps Container.
Device ID | K170513 |
510k Number | K170513 |
Device Name: | MAUSER PG II Sharps Container |
Classification | Container, Sharps |
Applicant | Mauzer USA LLC 2 Tower Center Drive, 20th Floor East Brunswick, NJ 08816 |
Contact | Tatiana Smoleeva |
Correspondent | Tatiana Smoleeva Mauzer USA LLC 2 Tower Center Drive, 20th Floor East Brunswick, NJ 08816 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-21 |
Decision Date | 2017-11-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859461007352 | K170513 | 000 |
00859461007161 | K170513 | 000 |
00859461007154 | K170513 | 000 |
00859461007147 | K170513 | 000 |
00859461007130 | K170513 | 000 |
00859461007123 | K170513 | 000 |
00859461007116 | K170513 | 000 |
00859461007109 | K170513 | 000 |
00859461007093 | K170513 | 000 |
00859461007086 | K170513 | 000 |
00859461007079 | K170513 | 000 |
00859461007062 | K170513 | 000 |
00859461007055 | K170513 | 000 |
00859461007048 | K170513 | 000 |
00859461007031 | K170513 | 000 |
00859461007024 | K170513 | 000 |
00859461007017 | K170513 | 000 |
00859461007178 | K170513 | 000 |
00859461007185 | K170513 | 000 |
00859461007345 | K170513 | 000 |
00859461007338 | K170513 | 000 |
00859461007321 | K170513 | 000 |
00859461007314 | K170513 | 000 |
00859461007307 | K170513 | 000 |
00859461007291 | K170513 | 000 |
00859461007284 | K170513 | 000 |
00859461007277 | K170513 | 000 |
00859461007260 | K170513 | 000 |
00859461007253 | K170513 | 000 |
00859461007246 | K170513 | 000 |
00859461007239 | K170513 | 000 |
00859461007222 | K170513 | 000 |
00859461007215 | K170513 | 000 |
00859461007208 | K170513 | 000 |
00859461007192 | K170513 | 000 |
00859461007000 | K170513 | 000 |