The following data is part of a premarket notification filed by Dhd Healthcare Corp. with the FDA for Lichen, Bacterial In Line Breathing Filter.
Device ID | K980662 |
510k Number | K980662 |
Device Name: | LICHEN, BACTERIAL IN LINE BREATHING FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville, NY 13163 |
Contact | Jean Wallace |
Correspondent | Jean Wallace DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville, NY 13163 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-20 |
Decision Date | 1998-09-14 |
Summary: | summary |