The following data is part of a premarket notification filed by Winner Industries (shenzhen) Co., Ltd. with the FDA for Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask With Shield.
| Device ID | K023755 |
| 510k Number | K023755 |
| Device Name: | WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD |
| Classification | Mask, Surgical |
| Applicant | WINNER INDUSTRIES (SHENZHEN) CO., LTD. 1900-H PROFORMA AVE. Ontario, CA 92861 |
| Contact | Ming Xie |
| Correspondent | Ming Xie WINNER INDUSTRIES (SHENZHEN) CO., LTD. 1900-H PROFORMA AVE. Ontario, CA 92861 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-08 |
| Decision Date | 2003-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H66810186101 | K023755 | 000 |
| 16941094021070 | K023755 | 000 |
| 06941094021844 | K023755 | 000 |
| D066PGMHL11 | K023755 | 000 |
| D066PGMBL32 | K023755 | 000 |
| D066PGMBL22 | K023755 | 000 |
| D066PGMBL12 | K023755 | 000 |
| D066PGMBK32 | K023755 | 000 |
| D066PGMBK22 | K023755 | 000 |
| 26941094021077 | K023755 | 000 |
| M3683813B2 | K023755 | 000 |
| H66810185101 | K023755 | 000 |
| H66810184101 | K023755 | 000 |
| H66810182101 | K023755 | 000 |
| H66810180101 | K023755 | 000 |
| H66810171101 | K023755 | 000 |
| H66810170101 | K023755 | 000 |
| M36838162 | K023755 | 000 |
| M36838142 | K023755 | 000 |
| D066PGMBK12 | K023755 | 000 |