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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 K140383
Device Name ALLOX2 TISSUE EXPANDERS
Applicant
Specialty Surgical Products, Inc.
1123 N. U.S. Hwy. 93
Victor,  MT  59875
Applicant Contact SHERRY NULL
Correspondent
Specialty Surgical Products, Inc.
1123 N. U.S. Hwy. 93
Victor,  MT  59875
Correspondent Contact SHERRY NULL
Classification Product Code
LCJ  
Date Received02/14/2014
Decision Date 10/28/2014
Decision Substantially Equivalent (SESE)
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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