ITO ACUPUNCTURE NEEDLES

Needle, Acupuncture, Single Use

OMS MEDICAL SUPPLIES, INC.

The following data is part of a premarket notification filed by Oms Medical Supplies, Inc. with the FDA for Ito Acupuncture Needles.

Pre-market Notification Details

Device IDK963194
510k NumberK963194
Device Name:ITO ACUPUNCTURE NEEDLES
ClassificationNeedle, Acupuncture, Single Use
Applicant OMS MEDICAL SUPPLIES, INC. 230 LIBBEY PKWY. Weymouth,  MA  02189
ContactThomas A Riihimaki
CorrespondentThomas A Riihimaki
OMS MEDICAL SUPPLIES, INC. 230 LIBBEY PKWY. Weymouth,  MA  02189
Product CodeMQX  
CFR Regulation Number880.5580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-15
Decision Date1996-08-23
Summary:summary

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