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FDA 510(k)

REPLACE-A-TIP ADJUSTABLE HIGH TEMP.

K-Number: K841509 · 1984-12-07

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

Device Summary

REPLACE-A-TIP ADJUSTABLE HIGH 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 K841509. 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 ADJUSTABLE HIGH TEMP.?

REPLACE-A-TIP ADJUSTABLE HIGH 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 K841509.

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

REPLACE-A-TIP ADJUSTABLE HIGH TEMP. received FDA 510(k) clearance on 1984-12-07, under 510(k) number K841509.

Who is the listed applicant for REPLACE-A-TIP ADJUSTABLE HIGH 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 ADJUSTABLE HIGH TEMP.?

The FDA product code for REPLACE-A-TIP ADJUSTABLE HIGH 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.

K841459REPLACE-A-TIP ADJUST. LOW 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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