The following data is part of a premarket notification filed by Tucker & Associates with the FDA for Latex Finger Cot, Powder-free, With Protein Labeling.
Device ID | K980827 |
510k Number | K980827 |
Device Name: | LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING |
Classification | Finger Cot |
Applicant | TUCKER & ASSOCIATES 198 AVE. DE LA D' EMERALD Sparks, NV 89434 -9550 |
Contact | Janna P Tucker |
Correspondent | Janna P Tucker TUCKER & ASSOCIATES 198 AVE. DE LA D' EMERALD Sparks, NV 89434 -9550 |
Product Code | LZB |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-03 |
Decision Date | 1998-05-04 |
Summary: | summary |