Sensicare Synthetic, Surgical Glove Liner

FDA 510(k) K950995 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Substantially Equivalent

510(k) numberK950995

Submission

Device name
Sensicare Synthetic, Surgical Glove Liner
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lake, NJ, US
Received
March 3, 1995
Decision date
June 28, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LYN – Apparatus, Visual Reinforcement Audiometric
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1050
Specialty
Ear, Nose, Throat

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K897143Vera 103LYN · Traditional Madsen North America, Inc.04/27/1990SE
K880259Visual Reinforce. Audio Cassette Unit: Basic & AdvLYN · Traditional Colorado Hearing Systems, Inc.04/03/1989SE

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Questions and answers

When was Sensicare Synthetic, Surgical Glove Liner cleared by the FDA?

Sensicare Synthetic, Surgical Glove Liner (K950995) received a 510(k) decision of Substantially Equivalent on June 28, 1995, 117 days after the submission was received.

What is the product code of K950995?

The FDA product code is LYN – Apparatus, Visual Reinforcement Audiometric, a Class II (moderate risk) device regulated under 21 CFR 874.1050.