The following data is part of a premarket notification filed by Kung Shin Plastics Co., Ltd. with the FDA for Kung Shin, Hmef Sk203.
| Device ID | K032878 |
| 510k Number | K032878 |
| Device Name: | KUNG SHIN, HMEF SK203 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | KUNG SHIN PLASTICS CO., LTD. NO.58 FU-CHIUN ST Hsin-chu City, TW 300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min KUNG SHIN PLASTICS CO., LTD. NO.58 FU-CHIUN ST Hsin-chu City, TW 300 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-15 |
| Decision Date | 2004-09-20 |