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FDA 510(k) Application Details - K140383
Device Classification Name
Expander, Skin, Inflatable
More FDA Info for this Device
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
More FDA Info for this Regulation Number
Classification Product Code
LCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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