The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Desensitron.
Device ID | K771130 |
510k Number | K771130 |
Device Name: | DESENSITRON |
Classification | Device, Iontophoresis, Other Uses |
Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-23 |
Decision Date | 1977-07-15 |