The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Comply Indicator Tape For Ethylene Oxide (eo) Sterilization.
| Device ID | K150477 |
| 510k Number | K150477 |
| Device Name: | 3M Comply Indicator Tape For Ethylene Oxide (EO) Sterilization |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BUILDING 275-5W-06 St. Paul, MN 55144 |
| Contact | Matt Mortensen |
| Correspondent | Matt Mortensen 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 | 2015-02-24 |
| Decision Date | 2015-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884389180478 | K150477 | 000 |