The following data is part of a premarket notification filed by Intec Industries, Inc. with the FDA for Intec Extended Eye Shield With Mask.
| Device ID | K946343 |
| 510k Number | K946343 |
| Device Name: | INTEC EXTENDED EYE SHIELD WITH MASK |
| Classification | Mask, Surgical |
| Applicant | INTEC INDUSTRIES, INC. 3804 FIRST AVENUE NORTH Birmingham, AL 35222 |
| Contact | Frank Lee |
| Correspondent | Frank Lee INTEC INDUSTRIES, INC. 3804 FIRST AVENUE NORTH Birmingham, AL 35222 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-30 |
| Decision Date | 1995-03-22 |