The following data is part of a premarket notification filed by Gtimd Llc with the FDA for Aqueduct 100 Cervical Dilator.
| Device ID | K160664 |
| 510k Number | K160664 |
| Device Name: | Aqueduct 100 Cervical Dilator |
| Classification | Catheter, Balloon, Dilation Of Cervical Canal |
| Applicant | GTIMD LLC 6 COLUMBIA DRIVE Amherst, NH 03031 |
| Contact | Richard Demello |
| Correspondent | Richard Demello GTIMD LLC 6 COLUMBIA DRIVE Amherst, NH 03031 |
| Product Code | PON |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-09 |
| Decision Date | 2016-08-01 |
| Summary: | summary |