The following data is part of a premarket notification filed by L H M Ent., Inc. with the FDA for Custom Trays, Kits.
| Device ID | K894610 |
| 510k Number | K894610 |
| Device Name: | CUSTOM TRAYS, KITS |
| Classification | Tray, Surgical, Instrument |
| Applicant | L H M ENT., INC. 855 VIRGINIA AVENUE, P.O. BOX 431 Palm Harbor, FL 34683 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb L H M ENT., INC. 855 VIRGINIA AVENUE, P.O. BOX 431 Palm Harbor, FL 34683 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1990-03-15 |