The following data is part of a premarket notification filed by Gorman Rupp Industries with the FDA for Disposable K-pads.
Device ID | K760910 |
510k Number | K760910 |
Device Name: | DISPOSABLE K-PADS |
Classification | Pack, Hot Or Cold, Water Circulating |
Applicant | GORMAN RUPP INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILO |
CFR Regulation Number | 890.5720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-27 |
Decision Date | 1976-12-16 |