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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Syringe, Air And/Or Water
510(k) Number K911756
Device Name POSTERIOR NASAL EPISTAXIS INSTRUMENTS
Applicant
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Applicant Contact ROBERT L.CASARSA
Correspondent
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Correspondent Contact ROBERT L.CASARSA
Regulation Number872.4565
Classification Product Code
ECB  
Date Received04/18/1991
Decision Date 10/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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