The following data is part of a premarket notification filed by Santa Barbara Medco, Inc. with the FDA for Medco Custom Ear Protector Mold Kit.
| Device ID | K821187 |
| 510k Number | K821187 |
| Device Name: | MEDCO CUSTOM EAR PROTECTOR MOLD KIT |
| Classification | Protector, Hearing (insert) |
| Applicant | SANTA BARBARA MEDCO, INC. 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 | 1982-04-27 |
| Decision Date | 1982-05-27 |