FDA 510(k)

SENSICARE SYNTHETIC, SURGICAL GLOVE LINER

K-Number: K950995 · 1995-06-28

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1995-06-28

Product CodeLYN

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

SENSICARE SYNTHETIC, SURGICAL GLOVE LINER is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1995-06-28 under 510(k) number K950995. The device is classified under product code LYN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSICARE SYNTHETIC, SURGICAL GLOVE LINER?

SENSICARE SYNTHETIC, SURGICAL GLOVE LINER is a medical device that received FDA 510(k) clearance on 1995-06-28. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K950995.

When did SENSICARE SYNTHETIC, SURGICAL GLOVE LINER receive FDA 510(k) clearance?

SENSICARE SYNTHETIC, SURGICAL GLOVE LINER received FDA 510(k) clearance on 1995-06-28, under 510(k) number K950995.

Who is the listed applicant for SENSICARE SYNTHETIC, SURGICAL GLOVE LINER?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSICARE SYNTHETIC, SURGICAL GLOVE LINER?

The FDA product code for SENSICARE SYNTHETIC, SURGICAL GLOVE LINER is LYN.

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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.