The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Basin, Sterile (#3200).
| Device ID | K760085 |
| 510k Number | K760085 |
| Device Name: | BASIN, STERILE (#3200) |
| Classification | Basin, Emesis |
| Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FNY |
| CFR Regulation Number | 880.6730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-21 |
| Decision Date | 1976-07-20 |