The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Spectra R Pad.
Device ID | K791013 |
510k Number | K791013 |
Device Name: | SPECTRA R PAD |
Classification | Media, Electroconductive |
Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GYB |
CFR Regulation Number | 882.1275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-01 |
Decision Date | 1979-09-17 |