The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Foerster Face Lift Drain.
Device ID | K800331 |
510k Number | K800331 |
Device Name: | SURGITEK FOERSTER FACE LIFT DRAIN |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-13 |
Decision Date | 1980-03-05 |