The following data is part of a premarket notification filed by Xanmed Corp. with the FDA for Surgical Eye Pack.
| Device ID | K851906 |
| 510k Number | K851906 |
| Device Name: | SURGICAL EYE PACK |
| Classification | Pad, Eye |
| Applicant | XANMED CORP. 815 CONNECTICUT AVENUE NW Washington , DC 20006 - |
| Contact | David B Vance |
| Correspondent | David B Vance XANMED CORP. 815 CONNECTICUT AVENUE NW Washington , DC 20006 - |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-01 |
| Decision Date | 1985-05-21 |