Who is the manufacturer of MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE?

Spectramed, Inc. filed the 510(k) submission for MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE (K880740).

What is the FDA product code for MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE?

DQF. It is classified under 21 CFR 870.1670 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE

K880740 · Spectramed, Inc. · DQF · Mar 22, 1988 · Cardiovascular

Device Facts

Record ID	K880740
Device Name	MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
Applicant	Spectramed, Inc.
Product Code	DQF · Cardiovascular
Decision Date	Mar 22, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1670
Device Class	Class 2

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