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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K802225
Device Name TENDER-SORB DRAIN SPONGES
Applicant
Kendall Research Center
411 Lake Zurich Rd.; P.O. Box 476
Barrington,  IL  60010
Applicant Contact Victor Kadar
Correspondent
Kendall Research Center
411 Lake Zurich Rd.; P.O. Box 476
Barrington,  IL  60010
Correspondent Contact Victor Kadar
Regulation Number878.4014
Classification Product Code
NAB  
Date Received09/12/1980
Decision Date 09/26/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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