The following data is part of a premarket notification filed by Doc's Proplugs, Inc. with the FDA for Doc's Proplugs Ear Plugs.
| Device ID | K862045 |
| 510k Number | K862045 |
| Device Name: | DOC'S PROPLUGS EAR PLUGS |
| Classification | Protector, Hearing (insert) |
| Applicant | DOC'S PROPLUGS, INC. 416 LIGHTHOUSE AVE. Santa Cruz, CA 95060 |
| Contact | Robert T Scott |
| Correspondent | Robert T Scott DOC'S PROPLUGS, INC. 416 LIGHTHOUSE AVE. Santa Cruz, CA 95060 |
| 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 | 1986-05-28 |
| Decision Date | 1987-04-10 |