The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Hygrobac,s Hygroboy And Hygrobaby.
| Device ID | K941381 |
| 510k Number | K941381 |
| Device Name: | HYGROBAC,S HYGROBOY AND HYGROBABY |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MALLINCKRODT MEDICAL HOOK RD. Argyle, NY 12809 |
| Contact | James C Webber |
| Correspondent | James C Webber MALLINCKRODT MEDICAL HOOK RD. Argyle, NY 12809 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-22 |
| Decision Date | 1994-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884522012274 | K941381 | 000 |
| 10884522035118 | K941381 | 000 |
| 40884522012349 | K941381 | 000 |