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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K894695
Device Name VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM
Applicant
Medistad Corp.
Wissahickon Ave. At Dickerson
P.O. Box 1097
North Wales,  PA  19454
Applicant Contact ALAN P SCHWARTZ
Correspondent
Medistad Corp.
Wissahickon Ave. At Dickerson
P.O. Box 1097
North Wales,  PA  19454
Correspondent Contact ALAN P SCHWARTZ
Regulation Number880.6740
Classification Product Code
GCX  
Date Received07/24/1989
Decision Date 01/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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