FDA 510(k)

CONTROL SYRINGE

K-Number: K960430 · 1996-08-06

ApplicantScientific Device Manufacturer, LLC

Decision Date1996-08-06

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CONTROL SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Device Manufacturer, LLC. It received FDA 510(k) clearance on 1996-08-06 under 510(k) number K960430. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROL SYRINGE?

CONTROL SYRINGE is a medical device that received FDA 510(k) clearance on 1996-08-06. The listed applicant is Scientific Device Manufacturer, LLC. The 510(k) number is K960430.

When did CONTROL SYRINGE receive FDA 510(k) clearance?

CONTROL SYRINGE received FDA 510(k) clearance on 1996-08-06, under 510(k) number K960430.

Who is the listed applicant for CONTROL SYRINGE?

The FDA 510(k) record lists Scientific Device Manufacturer, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTROL SYRINGE?

The FDA product code for CONTROL SYRINGE is DXT.

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Other records listing Scientific Device Manufacturer, LLC as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.