The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Medcrest Surgical Gowns And Surgical Drapes.
| Device ID | K982694 |
| 510k Number | K982694 |
| Device Name: | MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL 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 | Yes |
| Date Received | 1998-08-03 |
| Decision Date | 1998-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812564039699 | K982694 | 000 |
| 00812564038548 | K982694 | 000 |
| 00812564038456 | K982694 | 000 |
| 00812564038449 | K982694 | 000 |
| 00812564038432 | K982694 | 000 |
| 00812564038418 | K982694 | 000 |
| 00812564038340 | K982694 | 000 |
| 00812564038333 | K982694 | 000 |
| 00812564038319 | K982694 | 000 |
| 00812564038302 | K982694 | 000 |
| 00812564034861 | K982694 | 000 |
| 00812564037374 | K982694 | 000 |
| 00812564037367 | K982694 | 000 |
| 00812564038555 | K982694 | 000 |
| 00812564038807 | K982694 | 000 |
| 00812564039101 | K982694 | 000 |
| 00812564039675 | K982694 | 000 |
| 00812564039217 | K982694 | 000 |
| 00812564039200 | K982694 | 000 |
| 00812564039194 | K982694 | 000 |
| 00812564039187 | K982694 | 000 |
| 00812564039170 | K982694 | 000 |
| 00812564039163 | K982694 | 000 |
| 00812564039156 | K982694 | 000 |
| 00812564039149 | K982694 | 000 |
| 00812564039132 | K982694 | 000 |
| 00812564039125 | K982694 | 000 |
| 00812564039118 | K982694 | 000 |
| 00812564037329 | K982694 | 000 |