The following data is part of a premarket notification filed by Modern Healthcare Corp. with the FDA for Surgical Face Mask, Type: Tie-on, Ear-loop.
| Device ID | K063043 |
| 510k Number | K063043 |
| Device Name: | SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP |
| Classification | Mask, Surgical |
| Applicant | MODERN HEALTHCARE CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min MODERN HEALTHCARE CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-03 |
| Decision Date | 2007-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917174195 | K063043 | 000 |