The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Inline Foam Nose.
Device ID | K840398 |
510k Number | K840398 |
Device Name: | INLINE FOAM NOSE |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | MALLINCKRODT CRITICAL CARE 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-30 |
Decision Date | 1984-03-16 |