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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K920629
Device Name QUINEVAC II
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 Number878.5070
Classification Product Code
FYD  
Date Received02/12/1992
Decision Date 03/24/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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