BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY

Probe, Radiofrequency Lesion

BAYLIS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Baylis Pain Management Probe/pmp-20-145 And Baylis Pain Management Connector Cable/pmx-bay-bay.

Pre-market Notification Details

Device IDK002389
510k NumberK002389
Device Name:BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
ClassificationProbe, Radiofrequency Lesion
Applicant BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5 Mississauga,  CA L4w-4t7
ContactKris Shah
CorrespondentKris Shah
BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5 Mississauga,  CA L4w-4t7
Product CodeGXI  
CFR Regulation Number882.4725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-04
Decision Date2000-10-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10680651125108 K002389 000
10680651307481 K002389 000
10680651307498 K002389 000
10680651307504 K002389 000
10680651307511 K002389 000
10680651986617 K002389 000
10680651986624 K002389 000
10680651986631 K002389 000
10680651986648 K002389 000
10680651986655 K002389 000
10680651986662 K002389 000
10680651986679 K002389 000
10680651986693 K002389 000
10680651986709 K002389 000
10680651986716 K002389 000
10680651986723 K002389 000
10680651986730 K002389 000
10680651986747 K002389 000
10680651307474 K002389 000
10680651307467 K002389 000
10680651125115 K002389 000
10680651125221 K002389 000
10680651125450 K002389 000
10680651303902 K002389 000
10680651303919 K002389 000
10680651303926 K002389 000
10680651303933 K002389 000
10680651303940 K002389 000
10680651303957 K002389 000
10680651303964 K002389 000
10680651303971 K002389 000
10680651303988 K002389 000
10680651304459 K002389 000
10680651306040 K002389 000
10680651307436 K002389 000
10680651307443 K002389 000
10680651307450 K002389 000
10680651986792 K002389 000
10680651986839 K002389 000
10193493303974 K002389 000
10193493303981 K002389 000
10193493306043 K002389 000
10193493986733 K002389 000
10193493986740 K002389 000
10193493986795 K002389 000
10193493986832 K002389 000
10193493986856 K002389 000
10193493986863 K002389 000
10193493986894 K002389 000
10193493986917 K002389 000
10193493986948 K002389 000
10193493986979 K002389 000
10193493986986 K002389 000
10193493997111 K002389 000
10193493125224 K002389 000
10193493985958 K002389 000
10193493303967 K002389 000
10193493303950 K002389 000
10680651986853 K002389 000
10680651986860 K002389 000
10680651986891 K002389 000
10680651986914 K002389 000
10680651986945 K002389 000
10680651986976 K002389 000
10680651986983 K002389 000
10680651996685 K002389 000
10680651997118 K002389 000
10193493985927 K002389 000
10193493125101 K002389 000
10193493125118 K002389 000
10193493125453 K002389 000
10193493303912 K002389 000
10193493303929 K002389 000
10193493303936 K002389 000
10193493303943 K002389 000
10680651125511 K002389 000

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