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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Passer
510(k) Number K923381
Device Name SOFT TISSUE EXPANDER
Applicant
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact SUSAN GOLDSTEIN-FALK
Correspondent
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact SUSAN GOLDSTEIN-FALK
Regulation Number888.4540
Classification Product Code
HWQ  
Date Received07/09/1992
Decision Date 05/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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