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 |