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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tissue Expander And Accessories
510(k) Number K845036
FOIA Releasable 510(k) K845036
Device Name TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600
Applicant
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Applicant Contact ALFRED A IVERSEN
Correspondent
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Correspondent Contact ALFRED A IVERSEN
Classification Product Code
LCJ  
Date Received12/27/1984
Decision Date 06/26/1985
Decision Substantially Equivalent (SESE)
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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