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FDA 510(k)

SEDRATROL

K-Number: K940430 · 1995-02-06

ApplicantMedical Specialties Intl., Inc.
Decision Date1995-02-06
Product CodeGJR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SEDRATROL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties Intl., Inc.. It received FDA 510(k) clearance on 1995-02-06 under 510(k) number K940430. The device is classified under product code GJR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEDRATROL?

SEDRATROL is a medical device that received FDA 510(k) clearance on 1995-02-06. The listed applicant is Medical Specialties Intl., Inc.. The 510(k) number is K940430.

When did SEDRATROL receive FDA 510(k) clearance?

SEDRATROL received FDA 510(k) clearance on 1995-02-06, under 510(k) number K940430.

Who is the listed applicant for SEDRATROL?

The FDA 510(k) record lists Medical Specialties Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEDRATROL?

The FDA product code for SEDRATROL is GJR.

Related Clinical Trials

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Other records listing Medical Specialties Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972655CONTROL SYRINGEK972654MANIFOLDK952385HEMA-TROL Q-CHECKK895373HEMATOLOGY CONTROL

Related Devices (Code: GJR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K080016NRBC-CHEX FOR ADVIAStreckK060083NRBC-CHEX FOR LHStreckK000076CELL-CHEXStreck Laboratories, Inc.K900484RET-CHECKStreck Laboratories, Inc.

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.

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