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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K920628
Device Name QUINEVAC EVACUATOR/ASPIRATOR
Applicant
Recto Molded Products, Inc.
700 Thirteenth St. NW
Washington,  DC  20015
Applicant Contact SAMIA N RODRIGUEZ
Correspondent
Recto Molded Products, Inc.
700 Thirteenth St. NW
Washington,  DC  20015
Correspondent Contact SAMIA N RODRIGUEZ
Regulation Number878.4780
Classification Product Code
BTA  
Date Received02/12/1992
Decision Date 03/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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