The following data is part of a premarket notification filed by Sapimed S.p.a. with the FDA for Sapimed Disposable Sigmoidoscope.
| Device ID | K070915 |
| 510k Number | K070915 |
| Device Name: | SAPIMED DISPOSABLE SIGMOIDOSCOPE |
| Classification | Sigmoidoscope, Rigid, Non-electrical |
| Applicant | SAPIMED S.P.A. 1676 VILLAGE GREEN, SUITE A Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith SAPIMED S.P.A. 1676 VILLAGE GREEN, SUITE A Crofton, MD 21114 |
| Product Code | KDM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033638801567 | K070915 | 000 |
| 08033638800720 | K070915 | 000 |
| 08033638800270 | K070915 | 000 |
| 08033638800256 | K070915 | 000 |
| 08033638800218 | K070915 | 000 |
| 08033638800195 | K070915 | 000 |
| 08033638800171 | K070915 | 000 |