The following data is part of a premarket notification filed by Steven K. Juhn with the FDA for Middle Ear Viewer And Fluid Collector.
Device ID | K862903 |
510k Number | K862903 |
Device Name: | MIDDLE EAR VIEWER AND FLUID COLLECTOR |
Classification | Tube, Ear Suction |
Applicant | STEVEN K. JUHN GUTENKAUF 1300 FOSHAY TOWER Minneapolis, MN 55402 |
Contact | Bartz & |
Correspondent | Bartz & STEVEN K. JUHN GUTENKAUF 1300 FOSHAY TOWER Minneapolis, MN 55402 |
Product Code | JZF |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-31 |
Decision Date | 1986-11-24 |