ALLOX2 TISSUE EXPANDERS

Expander, Skin, Inflatable

SPECIALTY SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Specialty Surgical Products, Inc. with the FDA for Allox2 Tissue Expanders.

Pre-market Notification Details

Device IDK140383
510k NumberK140383
Device Name:ALLOX2 TISSUE EXPANDERS
ClassificationExpander, Skin, Inflatable
Applicant SPECIALTY SURGICAL PRODUCTS, INC. 1123 NORTH U.S. HWY. 93 Victor,  MT  59875
ContactSherry Null
CorrespondentSherry Null
SPECIALTY SURGICAL PRODUCTS, INC. 1123 NORTH U.S. HWY. 93 Victor,  MT  59875
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-14
Decision Date2014-10-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00819409020409 K140383 000
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00812790028269 K140383 000
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00812790028221 K140383 000
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00812790028313 K140383 000
00819409020355 K140383 000
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00812790028351 K140383 000
00812790028344 K140383 000
00812790028337 K140383 000
00812790028320 K140383 000
00812790028191 K140383 000

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