The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Disposable Surgical Drapes And Gowns.
| Device ID | K964142 |
| 510k Number | K964142 |
| Device Name: | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS |
| Classification | Drape, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Contact | Christine Galea |
| Correspondent | Christine Galea MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-16 |
| Decision Date | 1997-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902048524 | K964142 | 000 |
| 30801902055102 | K964142 | 000 |
| 20801902198864 | K964142 | 000 |
| 30801902099380 | K964142 | 000 |