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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 K921611
Device Name MADAVAC 190
Applicant
Mada Medical Products, Inc.
60 Commerce Rd.
Carlstadt,  NJ  07072
Applicant Contact JEFFREY W ADAM
Correspondent
Mada Medical Products, Inc.
60 Commerce Rd.
Carlstadt,  NJ  07072
Correspondent Contact JEFFREY W ADAM
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/03/1992
Decision Date 09/09/1992
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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