The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Flexlife.
Device ID | K952036 |
510k Number | K952036 |
Device Name: | FLEXLIFE |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
Contact | James C Webber |
Correspondent | James C Webber MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-01 |
Decision Date | 1995-06-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884522033633 | K952036 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLEXLIFE 97845980 not registered Live/Pending |
Magna Porta Sociedad Limitada 2023-03-19 |
FLEXLIFE 97181008 not registered Live/Pending |
People 2.0 Global, LLC 2021-12-20 |
FLEXLIFE 88895026 not registered Live/Pending |
Devan Kline Fitness, LLC 2020-04-30 |
FLEXLIFE 86613613 5821997 Live/Registered |
HOSCO FITTINGS, LLC 2015-04-29 |
FLEXLIFE 79069798 3715554 Dead/Cancelled |
Novo Nordisk A/S 2009-01-13 |
FLEXLIFE 76671712 not registered Dead/Abandoned |
FLEXLIFE LLC 2007-01-23 |
FLEXLIFE 74721088 2201662 Live/Registered |
RANDSTAD GENERAL PARTNER (US) LLC 1995-08-25 |
FLEXLIFE 73260420 1171621 Dead/Cancelled |
Inter-State Assurance Company 1980-05-01 |
FLEXLIFE 71337897 0307061 Dead/Expired |
STONE-TARLOW CO., INC. 1933-05-16 |