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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Oxygen, Topical, Extremity
510(k) Number K020466
Device Name HEC 1000
Applicant
Metro Medical Equipment, Inc.
12985 Wayne Rd.
Livonia,  MI  48150
Applicant Contact PAUL MOCUR
Correspondent
Metro Medical Equipment, Inc.
12985 Wayne Rd.
Livonia,  MI  48150
Correspondent Contact PAUL MOCUR
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received02/12/2002
Decision Date 05/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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