GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X

Elastomer, Silicone Block

IMPLANTECH ASSOCIATES INC.

The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for Gluteal Implant, Models Rnd 5-x, Trd 6-x.

Pre-market Notification Details

Device IDK052504
510k NumberK052504
Device Name:GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
ClassificationElastomer, Silicone Block
Applicant IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B Ventura,  CA  93003
ContactStephen Meade
CorrespondentStephen Meade
IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B Ventura,  CA  93003
Product CodeMIB  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-13
Decision Date2005-11-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724SGRTSCM51 K052504 000
M724CCB571 K052504 000
M724CCB561 K052504 000
M724CCB551 K052504 000
M724CCB6SIZ2NS1 K052504 000
M724CCB5SIZNC2NS1 K052504 000
M724CCB5SIZK2NS1 K052504 000
M724CCB641 K052504 000
M724CCB6SIZ3NS1 K052504 000
M724CCB6SIZ1NS1 K052504 000
M724CCB5SIZ4NS1 K052504 000
M724CCB5SIZ3NS1 K052504 000
M724CCB5SIZ2NS1 K052504 000
M724CCB5SIZ1NS1 K052504 000
M724CCB5SIZ0NS1 K052504 000
M724CCB5SIZ6NS1 K052504 000
M724CCB5SIZ5NS1 K052504 000
M724CCB5K11 K052504 000
M724CCB5NC31 K052504 000
M724CCB631 K052504 000
M724SGRTSCM41 K052504 000
M724SGRTSCM31 K052504 000
M724SGRTSCM21 K052504 000
M724SGRTSCL21 K052504 000
M724SGRTSCL11 K052504 000
M724CCB621 K052504 000
M724CCB611 K052504 000
M724CCB5NC21 K052504 000
M724CCB5NC11 K052504 000
M724CCB5K21 K052504 000
M724CCB541 K052504 000
M724CCB531 K052504 000
M724CCB521 K052504 000
M724CCB511 K052504 000
M724CCB501 K052504 000
M724SGRTSCM11 K052504 000
M724CCB64SIZNS1 K052504 000

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