The following data is part of a premarket notification filed by P.t. Maja Agung Latexindo with the FDA for Latex Examination Gloves-pre-powdered-sterile.
Device ID | K994255 |
510k Number | K994255 |
Device Name: | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE |
Classification | Latex Patient Examination Glove |
Applicant | P.T. MAJA AGUNG LATEXINDO 889 SOUTH AZUSA AVE. Industry, CA 91748 |
Contact | Emmy Tjoeng |
Correspondent | Emmy Tjoeng P.T. MAJA AGUNG LATEXINDO 889 SOUTH AZUSA AVE. Industry, CA 91748 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-17 |
Decision Date | 2000-02-07 |
Summary: | summary |