The following data is part of a premarket notification filed by Keymed (medical & Industrial Equipment), Ltd. with the FDA for Modified Keymed Flexible Esophageal Dilators.
| Device ID | K881478 |
| 510k Number | K881478 |
| Device Name: | MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS |
| Classification | Dilator, Esophageal |
| Applicant | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. KEYMED HOUSE,STOCK ROAD SOUTHEND-ON-SEA, ESSEX SS2 5QH Essex, GB |
| Contact | Roger Gray |
| Correspondent | Roger Gray KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. KEYMED HOUSE,STOCK ROAD SOUTHEND-ON-SEA, ESSEX SS2 5QH Essex, GB |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-06 |
| Decision Date | 1988-09-14 |