The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Sure-flex Anastomotic Balloon Dilator.
| Device ID | K901433 |
| 510k Number | K901433 |
| Device Name: | SURE-FLEX ANASTOMOTIC BALLOON DILATOR |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Contact | John A Chaves |
| Correspondent | John A Chaves TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-06-21 |