The following data is part of a premarket notification filed by Med-plastics Intl., Inc. with the FDA for Dispodable Heat & Moisture Exchanger And Filter/hme.
| Device ID | K946209 |
| 510k Number | K946209 |
| Device Name: | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
| Contact | Terry G Rosenkoetter |
| Correspondent | Terry G Rosenkoetter MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-21 |
| Decision Date | 1995-06-08 |