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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
Applicant Contact MARK D HEBENSTREIT
Correspondent
Medical Industries America, Inc.
2879 R Ave.
Adel,  IA  50003
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
Predetermined Change
Control Plan Authorized		 No
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