The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Fluidshield(tm) Cone Classic(tm) Ii Surgical Mask.
| Device ID | K911891 |
| 510k Number | K911891 |
| Device Name: | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Contact | Ruth L Jones |
| Correspondent | Ruth L Jones TECNOL NEW JERSEY WOUND CARE, 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 | 1991-04-29 |
| Decision Date | 1991-07-12 |