The following data is part of a premarket notification filed by Insitu Systems with the FDA for Manipuseal.
| Device ID | K051160 |
| 510k Number | K051160 |
| Device Name: | MANIPUSEAL |
| Classification | Culdoscope (and Accessories) |
| Applicant | INSITU SYSTEMS 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane INSITU SYSTEMS 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-05 |
| Decision Date | 2005-09-02 |
| Summary: | summary |