The following data is part of a premarket notification filed by Tucker & Associates with the FDA for Face Mask, Surgical Mask, Non-sterile.
| Device ID | K970835 |
| 510k Number | K970835 |
| Device Name: | FACE MASK, SURGICAL MASK, NON-STERILE |
| Classification | Mask, Surgical |
| Applicant | TUCKER & ASSOCIATES 19001 SOUTH RICHFIELD, SUITE 185 Green Valley, AZ 85614 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker TUCKER & ASSOCIATES 19001 SOUTH RICHFIELD, SUITE 185 Green Valley, AZ 85614 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-19 |
| Decision Date | 1997-09-03 |