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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cotton, Roll
510(k) Number K861338
Device Name DENTAL COTTON ROLLS, STERILE AND NON-STERILE
Applicant
Intl. Verbandstoff-Fabrik Schaffhau
Ch-8212 Neuhausen Am Rheinfall
Switzlerland,  CH
Applicant Contact AEBI
Correspondent
Intl. Verbandstoff-Fabrik Schaffhau
Ch-8212 Neuhausen Am Rheinfall
Switzlerland,  CH
Correspondent Contact AEBI
Regulation Number872.6050
Classification Product Code
EFN  
Date Received04/07/1986
Decision Date 08/06/1986
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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