The following data is part of a premarket notification filed by Santa Barbara Medco, Inc. with the FDA for Physicians Choice Silicone Ear Putty.
| Device ID | K823921 |
| 510k Number | K823921 |
| Device Name: | PHYSICIANS CHOICE SILICONE EAR PUTTY |
| Classification | Kit, Earmold, Impression |
| Applicant | SANTA BARBARA MEDCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDG |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-28 |
| Decision Date | 1983-03-28 |