The following data is part of a premarket notification filed by Micro Direct, Inc. with the FDA for Spirosafe Filter.
| Device ID | K973314 |
| 510k Number | K973314 |
| Device Name: | SPIROSAFE FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MICRO DIRECT, INC. 1485 LISBON ST. Lewiston, ME 04240 |
| Contact | David R Staszak |
| Correspondent | David R Staszak MICRO DIRECT, INC. 1485 LISBON ST. Lewiston, ME 04240 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-03 |
| Decision Date | 1997-11-21 |
| Summary: | summary |