The following data is part of a premarket notification filed by Lsi Solutions, Inc. with the FDA for Lsi Solutions Fornisee System Uterine Manipulator And Accessories.
| Device ID | K111014 |
| 510k Number | K111014 |
| Device Name: | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES |
| Classification | Culdoscope (and Accessories) |
| Applicant | LSI SOLUTIONS, INC. 7796 VICTOR-MENDON RD. New York, NY 14564 |
| Contact | Jude S Sauer, M.d. |
| Correspondent | Jude S Sauer, M.d. LSI SOLUTIONS, INC. 7796 VICTOR-MENDON RD. New York, NY 14564 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2012-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850200006391 | K111014 | 000 |
| 00850200006384 | K111014 | 000 |
| 00850200006377 | K111014 | 000 |
| 00850200006360 | K111014 | 000 |
| 00850200006322 | K111014 | 000 |
| 00850200006261 | K111014 | 000 |
| 10850200006237 | K111014 | 000 |
| 10850200006220 | K111014 | 000 |
| 10850200006213 | K111014 | 000 |