The following data is part of a premarket notification filed by Adept-med Intl., Inc. with the FDA for Visecera Retainer.
| Device ID | K802806 |
| 510k Number | K802806 |
| Device Name: | VISECERA RETAINER |
| Classification | Retainer, Surgical |
| Applicant | ADEPT-MED INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-07 |
| Decision Date | 1981-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 61324400006600 | K802806 | 000 |
| 61324400004200 | K802806 | 000 |
| 61324400003500 | K802806 | 000 |
| 61324400002800 | K802806 | 000 |
| 61324400001100 | K802806 | 000 |
| 00613244000004 | K802806 | 000 |