HYGROSTER
Condenser, Heat And Moisture (artificial Nose)
MALLINCKRODT MEDICAL
The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Hygroster.
Pre-market Notification Details
| 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 |
Trademark Results [HYGROSTER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYGROSTER 74193179 1752368 Dead/Cancelled |
MALLINCKRODT HOLDINGS B.V. 1991-08-09 |
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