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FDA 510(k)

SINGLE USE SYRINGE #103 PERSONAL MEDIC

K-Number: K831444 · 1983-09-12

ApplicantPacesetter Systems
Decision Date1983-09-12
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SINGLE USE SYRINGE #103 PERSONAL MEDIC is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831444. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE USE SYRINGE #103 PERSONAL MEDIC?

SINGLE USE SYRINGE #103 PERSONAL MEDIC is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Pacesetter Systems. The 510(k) number is K831444.

When did SINGLE USE SYRINGE #103 PERSONAL MEDIC receive FDA 510(k) clearance?

SINGLE USE SYRINGE #103 PERSONAL MEDIC received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831444.

Who is the listed applicant for SINGLE USE SYRINGE #103 PERSONAL MEDIC?

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

What is the FDA product code for SINGLE USE SYRINGE #103 PERSONAL MEDIC?

The FDA product code for SINGLE USE SYRINGE #103 PERSONAL MEDIC is FRN.

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Official Source

View on FDA Database →

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

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