The following data is part of a premarket notification filed by L H M Ent., Inc. with the FDA for Single-use, Sterile 4oz Bottle Contain 0.9% Saline.
| Device ID | K901078 |
| 510k Number | K901078 |
| Device Name: | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | L H M ENT., INC. 855 VIRGINIA AVENUE, P.O. BOX 431 Palm Harbor, FL 34683 |
| Contact | Pat Lamb |
| Correspondent | Pat Lamb L H M ENT., INC. 855 VIRGINIA AVENUE, P.O. BOX 431 Palm Harbor, FL 34683 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-07 |
| Decision Date | 1990-05-18 |