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 |