SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313

Adaptor, Shunt

AKCESS MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Saf-t-shunt Silicone Rubber U, Prod. Code S-313.

Pre-market Notification Details

Device IDK892667
510k NumberK892667
Device Name:SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313
ClassificationAdaptor, Shunt
Applicant AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick,  NJ  08901
ContactBalbir Kapany
CorrespondentBalbir Kapany
AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick,  NJ  08901
Product CodeFKN  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-13
Decision Date1989-05-04

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