The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Warm N Wet Hme W/luer Adapter.
Device ID | K953619 |
510k Number | K953619 |
Device Name: | WARM N WET HME W/LUER ADAPTER |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | HOSPITAK, INC. 10 DANIEL ST. Farmingdale, NY 11735 |
Contact | William Laccy |
Correspondent | William Laccy HOSPITAK, INC. 10 DANIEL ST. Farmingdale, NY 11735 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-03 |
Decision Date | 1995-08-25 |