The following data is part of a premarket notification filed by Mcghan Medical Corp. with the FDA for Pro-mold, Custom Ear.
| Device ID | K781491 |
| 510k Number | K781491 |
| Device Name: | PRO-MOLD, CUSTOM EAR |
| Classification | Protector, Hearing (insert) |
| Applicant | MCGHAN MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EWD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-28 |
| Decision Date | 1978-09-27 |