AIR ASPIRATOR NEEDLE

Instruments, Surgical, Cardiovascular

TEXAS MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Air Aspirator Needle.

Pre-market Notification Details

Device IDK801393
510k NumberK801393
Device Name:AIR ASPIRATOR NEEDLE
ClassificationInstruments, Surgical, Cardiovascular
Applicant TEXAS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDWS  
CFR Regulation Number870.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-13
Decision Date1980-06-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B0662010150000 K801393 000
B0662010100006 K801393 000
B0662010050006 K801393 000
B066201015NS1 K801393 000
B066201010NS1 K801393 000
B066201005NS6 K801393 000

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