The following data is part of a premarket notification filed by Dhd Diemolding Healthcare Div. with the FDA for Duralife.
Device ID | K922537 |
510k Number | K922537 |
Device Name: | DURALIFE |
Classification | Connector, Airway (extension) |
Applicant | DHD DIEMOLDING HEALTHCARE DIV. 125 RASBACH ST. Canastota, NY 13032 |
Contact | Jean Wallace |
Correspondent | Jean Wallace DHD DIEMOLDING HEALTHCARE DIV. 125 RASBACH ST. Canastota, NY 13032 |
Product Code | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-28 |
Decision Date | 1992-12-04 |