The following data is part of a premarket notification filed by Landmark Plastics with the FDA for Basin, Round Wash.
Device ID | K760494 |
510k Number | K760494 |
Device Name: | BASIN, ROUND WASH |
Classification | Basin, Emesis |
Applicant | LANDMARK PLASTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FNY |
CFR Regulation Number | 880.6730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-23 |
Decision Date | 1976-11-12 |