The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sterile And Non-sterile O.r. Towels, Sterile And Non-sterile X-ray Detectable O.r. Towels, Single Use.
| Device ID | K962205 |
| 510k Number | K962205 |
| Device Name: | STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE |
| Classification | Drape, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 -4486 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons 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 | 1996-06-07 |
| Decision Date | 1996-11-26 |