Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Unit, Examining/Treatment, Ent
510(k) Number K932470
Device Name LANGGASSE 90
Applicant
HAPPERSBERGER OTOPRONT GMBH
D-6209 HOHENSTEIN
1 P.O. BOX
GERMANY,  GR
Applicant Contact MARC STRELOW
Correspondent
HAPPERSBERGER OTOPRONT GMBH
D-6209 HOHENSTEIN
1 P.O. BOX
GERMANY,  GR
Correspondent Contact MARC STRELOW
Regulation Number874.5300
Classification Product Code
ETF  
Date Received05/20/1993
Decision Date 08/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-