The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Blockade Or Resistat Surgical Gowns And Surggical Drapes.
| Device ID | K003755 |
| 510k Number | K003755 |
| Device Name: | MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES |
| Classification | Gown, 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-05 |
| Decision Date | 2001-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812564039897 | K003755 | 000 |
| 00812564037404 | K003755 | 000 |
| 00812564037398 | K003755 | 000 |
| 00812564037350 | K003755 | 000 |
| 00810019800030 | K003755 | 000 |
| 00810019801068 | K003755 | 000 |
| 00810019801051 | K003755 | 000 |
| 00810019801044 | K003755 | 000 |
| 00810019801013 | K003755 | 000 |
| 00810019800993 | K003755 | 000 |
| 00810019800979 | K003755 | 000 |
| 00810019800962 | K003755 | 000 |
| 00810019800955 | K003755 | 000 |
| 00810019800948 | K003755 | 000 |
| 00810019800931 | K003755 | 000 |
| 00810019800900 | K003755 | 000 |
| 00810019800986 | K003755 | 000 |
| 00812564030306 | K003755 | 000 |
| 00812564030313 | K003755 | 000 |
| 00812564030320 | K003755 | 000 |
| 00812564039880 | K003755 | 000 |
| 00812564039873 | K003755 | 000 |
| 00812564039866 | K003755 | 000 |
| 00812564039859 | K003755 | 000 |
| 00812564039460 | K003755 | 000 |
| 00812564039453 | K003755 | 000 |
| 00812564039408 | K003755 | 000 |
| 00812564039361 | K003755 | 000 |
| 00812564039224 | K003755 | 000 |
| 00812564032478 | K003755 | 000 |
| 00812564030399 | K003755 | 000 |
| 00812564030382 | K003755 | 000 |
| 00812564030375 | K003755 | 000 |
| 00812564030368 | K003755 | 000 |
| 00812564030344 | K003755 | 000 |
| 00812564030337 | K003755 | 000 |
| 00810019801761 | K003755 | 000 |