MAGNETIC PORT SILICONE TISSUE EXPANDER

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 Magnetic Port Silicone Tissue Expander.

Pre-market Notification Details

Device IDK982067
510k NumberK982067
Device Name:MAGNETIC PORT SILICONE TISSUE EXPANDER
ClassificationExpander, Skin, Inflatable
Applicant SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton,  MT  59840
ContactT. Jan Varner
CorrespondentT. Jan Varner
SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton,  MT  59840
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-12
Decision Date1998-07-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.