The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Hygroster.
Device ID | K941585 |
510k Number | K941585 |
Device Name: | HYGROSTER |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
Contact | James C Webber |
Correspondent | James C Webber MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-31 |
Decision Date | 1994-04-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYGROSTER 74193179 1752368 Dead/Cancelled |
MALLINCKRODT HOLDINGS B.V. 1991-08-09 |