The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Comply Hydrogen Peroxide Indicator Tape.
Device ID | K170563 |
510k Number | K170563 |
Device Name: | 3M Comply Hydrogen Peroxide Indicator Tape |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | 3M Company 3M Center, Building 275-5W-06 St. Paul, MN 55144 |
Contact | Nadia Battah |
Correspondent | Nadia Battah 3M Company 3M Center, Building 275-5W-06 St. Paul, MN 55144 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-27 |
Decision Date | 2017-07-27 |
Summary: | summary |