FDA 510(k)

DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES

K-Number: K950012 · 1995-08-18

ApplicantInternational Regulatory Consultants

Decision Date1995-08-18

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is International Regulatory Consultants. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K950012. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES?

DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is International Regulatory Consultants. The 510(k) number is K950012.

When did DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES receive FDA 510(k) clearance?

DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES received FDA 510(k) clearance on 1995-08-18, under 510(k) number K950012.

Who is the listed applicant for DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES?

The FDA 510(k) record lists International Regulatory Consultants as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES?

The FDA product code for DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES is FMI.

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Other records listing International Regulatory Consultants as applicant

K981591VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT K971347MEDISURF K962614SHIFA STERILE DISPOSABLE SYRINGES K935280MEMOTHERM 10 BABY THERMOMETER

Related Devices (Code: FMI)

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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.