The following data is part of a premarket notification filed by Xanmed Corp. with the FDA for Obstetrical/gynecological Custom Surgical Kit.
| Device ID | K864623 |
| 510k Number | K864623 |
| Device Name: | OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | XANMED CORP. 85V. HOFFMAN LN. Central Islip, NY 11722 |
| Contact | Patricia Clancy |
| Correspondent | Patricia Clancy XANMED CORP. 85V. HOFFMAN LN. Central Islip, NY 11722 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-25 |
| Decision Date | 1987-01-14 |