The following data is part of a premarket notification filed by Lhb Industries, Inc. with the FDA for Body Fluid Barrier Kit.
| Device ID | K952961 |
| 510k Number | K952961 |
| Device Name: | BODY FLUID BARRIER KIT |
| Classification | Mask, Surgical |
| Applicant | LHB INDUSTRIES, INC. 10616 TRENTON AVENUE St. Louis, MO 63132 |
| Contact | Edward R Lanser |
| Correspondent | Edward R Lanser LHB INDUSTRIES, INC. 10616 TRENTON AVENUE St. Louis, MO 63132 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-26 |
| Decision Date | 1996-01-23 |