The following data is part of a premarket notification filed by Sapimed S.p.a. with the FDA for Self-light Disposable Anoscope.
| Device ID | K070913 |
| 510k Number | K070913 |
| Device Name: | SELF-LIGHT DISPOSABLE ANOSCOPE |
| Classification | Anoscope And Accessories |
| 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 | FER |
| 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 | 2007-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033638802892 | K070913 | 000 |
| 08033638800034 | K070913 | 000 |
| 08033638800058 | K070913 | 000 |
| 08033638800072 | K070913 | 000 |
| 08033638800096 | K070913 | 000 |
| 08033638800119 | K070913 | 000 |
| 08033638800133 | K070913 | 000 |
| 08033638800157 | K070913 | 000 |
| 08033638800447 | K070913 | 000 |
| 08033638803585 | K070913 | 000 |
| 08033638801260 | K070913 | 000 |
| 08033638801369 | K070913 | 000 |
| 08033638800003 | K070913 | 000 |