The following data is part of a premarket notification filed by H & P Industries, Inc. with the FDA for Providone-iodine Prep-pads & Towelettes.
Device ID | K830394 |
510k Number | K830394 |
Device Name: | PROVIDONE-IODINE PREP-PADS & TOWELETTES |
Classification | Brush, Scrub, Operating-room |
Applicant | H & P INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-07 |
Decision Date | 1983-04-06 |