The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Steri-drape Chg Antimicrobial Incise Drape.
Device ID | K140250 |
510k Number | K140250 |
Device Name: | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE |
Classification | Drape, Surgical |
Applicant | 3M HEALTH CARE 3M CENTER, 2510 CONWAY AVE. BLDG 275-5W-06 St. Paul, MN 55144 |
Contact | Kristin Totushek |
Correspondent | Kristin Totushek 3M HEALTH CARE 3M CENTER, 2510 CONWAY AVE. BLDG 275-5W-06 St. Paul, MN 55144 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-31 |
Decision Date | 2014-07-25 |
Summary: | summary |