The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Silvertouch 100% Silicone Foley Catheter, Model Medline Industries, Inc..
| Device ID | K052168 |
| 510k Number | K052168 |
| Device Name: | MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. |
| Classification | Catheter, Retention Type, Balloon |
| 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 | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-09 |
| Decision Date | 2006-02-16 |
| Summary: | summary |