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FDA 510(k)

REPLACE-A-TIP ADJUST. LOW TEMP.-

K-Number: K841459 · 1984-12-07

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-12-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPLACE-A-TIP ADJUST. LOW TEMP.- is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1984-12-07 under 510(k) number K841459. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPLACE-A-TIP ADJUST. LOW TEMP.-?

REPLACE-A-TIP ADJUST. LOW TEMP.- is a medical device that received FDA 510(k) clearance on 1984-12-07. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K841459.

When did REPLACE-A-TIP ADJUST. LOW TEMP.- receive FDA 510(k) clearance?

REPLACE-A-TIP ADJUST. LOW TEMP.- received FDA 510(k) clearance on 1984-12-07, under 510(k) number K841459.

Who is the listed applicant for REPLACE-A-TIP ADJUST. LOW TEMP.-?

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

What is the FDA product code for REPLACE-A-TIP ADJUST. LOW TEMP.-?

The FDA product code for REPLACE-A-TIP ADJUST. LOW TEMP.- is GEI.

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Other records listing Suncoast Medical Manufacturers, 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.

K841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841604ADJUST-A-TEMP HIGH TEMPERATUREK841603ADJUST-A-TEMP MICROK841591PYRO-TIPK840376SURG-A STAT LOOP TIPK840377SURG-A-STAT CARDIOVASCULAR TIP

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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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