The following data is part of a premarket notification filed by Apollo Endosurgery, Inc. with the FDA for Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00.
| Device ID | K082114 |
| 510k Number | K082114 |
| Device Name: | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 Austin, TX 78746 |
| Contact | Dennis Mcwilliams |
| Correspondent | Dennis Mcwilliams APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 Austin, TX 78746 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-28 |
| Decision Date | 2008-12-19 |
| Summary: | summary |