The following data is part of a premarket notification filed by 3m Company with the FDA for Futuro (tm) Travel Knee-highs; Futuro (tm) Travel Socks; Futuro (tm) Travel Stockings; Futuro (tm) Travel Pantyhose.
Device ID | K123085 |
510k Number | K123085 |
Device Name: | FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | 3M COMPANY 2510 CONWAY AVENUE St. Paul, MN 55144 |
Contact | Lisa Nelson |
Correspondent | Lisa Nelson 3M COMPANY 2510 CONWAY AVENUE St. Paul, MN 55144 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-01 |
Decision Date | 2012-12-20 |
Summary: | summary |