The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Ear Stopples For Noise Attention.
| Device ID | K781907 |
| 510k Number | K781907 |
| Device Name: | EAR STOPPLES FOR NOISE ATTENTION |
| Classification | Protector, Hearing (insert) |
| Applicant | CROWN DELTA CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1978-11-14 |
| Decision Date | 1978-11-22 |