The following data is part of a premarket notification filed by Pilling Weck Surgical with the FDA for Jackson Esophageal Dilator.
| Device ID | K990935 |
| 510k Number | K990935 |
| Device Name: | JACKSON ESOPHAGEAL DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-19 |
| Decision Date | 1999-05-17 |
| Summary: | summary |