The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Modification To: 3-lumen Duralon Occlusion Balloon.
| Device ID | K013737 |
| 510k Number | K013737 |
| Device Name: | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Contact | Michael Carroll |
| Correspondent | Michael Carroll TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813353010172 | K013737 | 000 |
| 00813353010165 | K013737 | 000 |