The following data is part of a premarket notification filed by Cosmedtech, Inc. with the FDA for Cosmedtech Cannula.
Device ID | K870560 |
510k Number | K870560 |
Device Name: | COSMEDTECH CANNULA |
Classification | System, Abortion, Vacuum |
Applicant | COSMEDTECH, INC. 5633 VIA SALEROSA Tucson, AZ 85715 |
Contact | John M Johnson |
Correspondent | John M Johnson COSMEDTECH, INC. 5633 VIA SALEROSA Tucson, AZ 85715 |
Product Code | HHI |
CFR Regulation Number | 884.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-10 |
Decision Date | 1987-03-04 |