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 |