FDA 510(k) Application Details - K140383

Device Classification Name Expander, Skin, Inflatable

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510(K) Number K140383
Device Name Expander, Skin, Inflatable
Applicant SPECIALTY SURGICAL PRODUCTS, INC.
1123 NORTH U.S. HWY. 93
VICTOR, MT 59875 US
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Contact SHERRY NULL
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Regulation Number 000.0000

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Classification Product Code LCJ
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Date Received 02/14/2014
Decision Date 10/28/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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