The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Prohibit Series Surgical Mask With Fluid Shield.
| Device ID | K991559 |
| 510k Number | K991559 |
| Device Name: | MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD |
| Classification | Mask, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-04 |
| Decision Date | 1999-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40080196754404 | K991559 | 000 |
| 30080196752953 | K991559 | 000 |