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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
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