DURALASTIC SILICONE TUBING

Accessories, Catheter

ALLIED BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Duralastic Silicone Tubing.

Pre-market Notification Details

Device IDK955433
510k NumberK955433
Device Name:DURALASTIC SILICONE TUBING
ClassificationAccessories, Catheter
Applicant ALLIED BIOMEDICAL CORP. 3850 DR. #C-2 Paso Robles,  CA  93446
ContactGerald Hanson
CorrespondentGerald Hanson
ALLIED BIOMEDICAL CORP. 3850 DR. #C-2 Paso Robles,  CA  93446
Product CodeKGZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-28
Decision Date1996-01-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724PAT111 K955433 000
M724HAT221 K955433 000
M724HAT211 K955433 000
M724HAT201 K955433 000
M724HAT191 K955433 000
M724HAT181 K955433 000
M724HAT171 K955433 000
M724HAT161 K955433 000
M724HAT151 K955433 000
M724HAT141 K955433 000
M724HAT131 K955433 000
M724HAT231 K955433 000
M724HAT241 K955433 000
M724PAT101 K955433 000
M724PAT091 K955433 000
M724PAT081 K955433 000
M724PAT071 K955433 000
M724PAT061 K955433 000
M724PAT051 K955433 000
M724PAT041 K955433 000
M724PAT031 K955433 000
M724PAT021 K955433 000
M724PAT011 K955433 000
M724HAT121 K955433 000

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