RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)

Expander, Skin, Inflatable

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Radovan Tissue Expander (option Integral Inject.).

Pre-market Notification Details

Device IDK884250
510k NumberK884250
Device Name:RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
ClassificationExpander, Skin, Inflatable
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactByron Wickett
CorrespondentByron Wickett
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-11
Decision Date1989-06-12

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