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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 K843539
Device Name TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-
Applicant
Molnlycke A/S Hospital Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Molnlycke A/S Hospital Products
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.6050
Classification Product Code
EFN  
Date Received09/07/1984
Decision Date 05/23/1985
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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