The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Disposable Bacterial Breathng Filter.
Device ID | K915750 |
510k Number | K915750 |
Device Name: | DISPOSABLE BACTERIAL BREATHNG FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
Contact | William J Lacey |
Correspondent | William J Lacey HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-19 |
Decision Date | 1994-11-30 |