The following data is part of a premarket notification filed by Tecnol Medical Products, Inc. with the FDA for Fluidshield Surgical/procedure Mask/m. With Visor.
| Device ID | K932137 |
| 510k Number | K932137 |
| Device Name: | FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR |
| Classification | Mask, Surgical |
| Applicant | TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Contact | Leona M Hammel |
| Correspondent | Leona M Hammel TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-27 |
| Decision Date | 1994-04-15 |