MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION

Prosthesis, Toe, Hemi-, Phalangeal

VILEX, INC.

The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Met-head Model# Mhdd-xx:cc Diameter, Cc Cannulation.

Pre-market Notification Details

Device IDK070052
510k NumberK070052
Device Name:MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
ClassificationProsthesis, Toe, Hemi-, Phalangeal
Applicant VILEX, INC. 345 OLD CURRY HOLLOW RD. Pittsburgh,  PA  15236
ContactAbraham Lavi
CorrespondentAbraham Lavi
VILEX, INC. 345 OLD CURRY HOLLOW RD. Pittsburgh,  PA  15236
Product CodeKWD  
CFR Regulation Number888.3730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-04
Decision Date2007-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841731106469 K070052 000
00841731106339 K070052 000
00841731106346 K070052 000
00841731106353 K070052 000
00841731106360 K070052 000
00841731106421 K070052 000
00841731106438 K070052 000
00841731106445 K070052 000
00841731106452 K070052 000
00841731106322 K070052 000

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