The following data is part of a premarket notification filed by Sorensen Research with the FDA for Accurate Measurement Device Ez-amd.
Device ID | K833673 |
510k Number | K833673 |
Device Name: | ACCURATE MEASUREMENT DEVICE EZ-AMD |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | SORENSEN RESEARCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-18 |
Decision Date | 1983-12-29 |