The following data is part of a premarket notification filed by Irema Usa Ltd. with the FDA for Disposable Surgical Face Mask.
| Device ID | K875172 |
| 510k Number | K875172 |
| Device Name: | DISPOSABLE SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | IREMA USA LTD. 1441 MAIN ST. SUITE 1100 Springfield, MA 01103 |
| Contact | Robert Meeropol |
| Correspondent | Robert Meeropol IREMA USA LTD. 1441 MAIN ST. SUITE 1100 Springfield, MA 01103 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00366975002044 | K875172 | 000 |
| 10817583020366 | K875172 | 000 |
| 10817583020373 | K875172 | 000 |
| 10817583020380 | K875172 | 000 |
| 10817583020397 | K875172 | 000 |
| 10817583020403 | K875172 | 000 |
| 10817583020410 | K875172 | 000 |
| 10817583020427 | K875172 | 000 |
| 10817583020434 | K875172 | 000 |
| 10817583020441 | K875172 | 000 |
| 10817583020458 | K875172 | 000 |
| 10817583020465 | K875172 | 000 |
| 10817583020472 | K875172 | 000 |
| 10817583020489 | K875172 | 000 |
| 10817583020496 | K875172 | 000 |
| 00366975002020 | K875172 | 000 |
| 00366975002037 | K875172 | 000 |
| 10817583020359 | K875172 | 000 |