The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Steri-vac Sterilizer/aerator.
Device ID | K142034 |
510k Number | K142034 |
Device Name: | 3M STERI-VAC STERILIZER/AERATOR |
Classification | Sterilizer, Ethylene-oxide Gas |
Applicant | 3M COMPANY 3M CENTER, BUILDING 275-SW-06 St. Paul, MN 55144 |
Contact | Matt Mortensen |
Correspondent | Matt Mortensen 3M COMPANY 3M CENTER, BUILDING 275-SW-06 St. Paul, MN 55144 |
Product Code | FLF |
CFR Regulation Number | 880.6860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-28 |
Decision Date | 2015-01-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50707387767278 | K142034 | 000 |
50707387767261 | K142034 | 000 |
50707387767254 | K142034 | 000 |
50707387767247 | K142034 | 000 |
00707387787578 | K142034 | 000 |
00707387787561 | K142034 | 000 |
00707387787028 | K142034 | 000 |
00707387787011 | K142034 | 000 |