The following data is part of a premarket notification filed by Gynetech Pty. Ltd. with the FDA for Mccartney Access Tube.
| Device ID | K051594 |
| 510k Number | K051594 |
| Device Name: | MCCARTNEY ACCESS TUBE |
| Classification | Culdoscope (and Accessories) |
| Applicant | GYNETECH PTY. LTD. 4545 CREEK ROAD Cincinnati, OH 45242 -2839 |
| Contact | Dennis Hahn |
| Correspondent | Dennis Hahn GYNETECH PTY. LTD. 4545 CREEK ROAD Cincinnati, OH 45242 -2839 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-16 |
| Decision Date | 2005-09-02 |
| Summary: | summary |