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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, Internal
510(k) Number K880208
Device Name INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION
Applicant
Dresser Argus, Inc.
36 Bridge St.
Brooklyn,  NY  11201
Applicant Contact WARREN FRANK
Correspondent
Dresser Argus, Inc.
36 Bridge St.
Brooklyn,  NY  11201
Correspondent Contact WARREN FRANK
Classification Product Code
EFQ  
Date Received01/15/1988
Decision Date 04/12/1988
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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