SDR (SOFT DISSECTOR RAKE)

Laparoscope, General & Plastic Surgery

PHX TECHNOLOGIES CORP.

The following data is part of a premarket notification filed by Phx Technologies Corp. with the FDA for Sdr (soft Dissector Rake).

Pre-market Notification Details

Device IDK935109
510k NumberK935109
Device Name:SDR (SOFT DISSECTOR RAKE)
ClassificationLaparoscope, General & Plastic Surgery
Applicant PHX TECHNOLOGIES CORP. POST OFFICE BOX 1059 Lewisville,  TX  75067
ContactJames F Chapel
CorrespondentJames F Chapel
PHX TECHNOLOGIES CORP. POST OFFICE BOX 1059 Lewisville,  TX  75067
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-25
Decision Date1994-03-21

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