The following data is part of a premarket notification filed by Milex Products, Inc. with the FDA for Curette, Proposed Tis-u-trap, Metal.
Device ID | K760264 |
510k Number | K760264 |
Device Name: | CURETTE, PROPOSED TIS-U-TRAP, METAL |
Classification | Curette, Suction, Endometrial (and Accessories) |
Applicant | MILEX PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHK |
CFR Regulation Number | 884.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-21 |
Decision Date | 1976-10-06 |