The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Sigmoidoscope/ Disposable.
| Device ID | K761180 |
| 510k Number | K761180 |
| Device Name: | SIGMOIDOSCOPE/ DISPOSABLE |
| Classification | Sigmoidoscope And Accessories, Flexible/rigid |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-02 |
| Decision Date | 1977-01-05 |