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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 K941961
Device Name 605 VACU-MAX
Applicant
MEDICAL INDUSTRIES AMERICA, INC.
2879 R AVE.
ADEL,  IA  50003 -8055
Applicant Contact MARK D HEBENSTREIT
Correspondent
MEDICAL INDUSTRIES AMERICA, INC.
2879 R AVE.
ADEL,  IA  50003 -8055
Correspondent Contact MARK D HEBENSTREIT
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/22/1994
Decision Date 03/02/1995
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
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