FDA 510(k) Application Details - K070303

Device Classification Name Expander, Skin, Inflatable

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510(K) Number K070303
Device Name Expander, Skin, Inflatable
Applicant SPECIALTY SURGICAL PRODUCTS
1131 US HIGHWAY 93 NORTH
VICTOR, MT 59875 US
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Contact ANGELA LAWRENCE
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Regulation Number 000.0000

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Classification Product Code LCJ
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Date Received 01/31/2007
Decision Date 06/22/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K070303


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