The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Stone And Retrieval Basket.
Device ID | K792344 |
510k Number | K792344 |
Device Name: | STONE AND RETRIEVAL BASKET |
Classification | Dislodger, Stone, Basket, Ureteral, Metal |
Applicant | MILL-ROSE LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FFL |
CFR Regulation Number | 876.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-19 |
Decision Date | 1979-12-20 |