The following data is part of a premarket notification filed by Acme Filter Mask Inc. with the FDA for Acme Surgical Face Mask With Ear-loop Model Yn-501 Ab/w/g/p.
| Device ID | K123115 |
| 510k Number | K123115 |
| Device Name: | ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P |
| Classification | Mask, Surgical |
| Applicant | ACME FILTER MASK INC. NO. 57 HU SHAN ROAD YINGGE DISTRICT New Taipei City, TW 23941 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min ACME FILTER MASK INC. NO. 57 HU SHAN ROAD YINGGE DISTRICT New Taipei City, TW 23941 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-03 |
| Decision Date | 2013-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814639024972 | K123115 | 000 |