The following data is part of a premarket notification filed by Tools For Surgery, Llc with the FDA for Easy Loop, Model Ezl-01.
| Device ID | K040110 |
| 510k Number | K040110 |
| Device Name: | EASY LOOP, MODEL EZL-01 |
| Classification | Rod, Colostomy |
| Applicant | TOOLS FOR SURGERY, LLC 1339 STONY BROOK ROAD Stony Brook, NY 11790 |
| Contact | Arnold R Leiboff |
| Correspondent | Arnold R Leiboff TOOLS FOR SURGERY, LLC 1339 STONY BROOK ROAD Stony Brook, NY 11790 |
| Product Code | EZP |
| CFR Regulation Number | 876.4270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-03-24 |
| Summary: | summary |