The following data is part of a premarket notification filed by J.singh Instruments with the FDA for Singhmed Roolip Manipulator.
| Device ID | K110819 |
| 510k Number | K110819 |
| Device Name: | SINGHMED ROOLIP MANIPULATOR |
| Classification | Culdoscope (and Accessories) |
| Applicant | J.SINGH INSTRUMENTS 611 WEST 5TH STREET 3RD FLOOR Austin, TX 78701 |
| Contact | Caroline Tontini |
| Correspondent | Caroline Tontini J.SINGH INSTRUMENTS 611 WEST 5TH STREET 3RD FLOOR Austin, TX 78701 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-23 |
| Decision Date | 2011-10-05 |
| Summary: | summary |