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FDA 510(k)

SURG-A-STAT LOOP TIP 2

K-Number: K840387 · 1984-07-23

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-07-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURG-A-STAT LOOP TIP 2 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 1984-07-23 under 510(k) number K840387. 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 SURG-A-STAT LOOP TIP 2?

SURG-A-STAT LOOP TIP 2 is a medical device that received FDA 510(k) clearance on 1984-07-23. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K840387.

When did SURG-A-STAT LOOP TIP 2 receive FDA 510(k) clearance?

SURG-A-STAT LOOP TIP 2 received FDA 510(k) clearance on 1984-07-23, under 510(k) number K840387.

Who is the listed applicant for SURG-A-STAT LOOP TIP 2?

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 SURG-A-STAT LOOP TIP 2?

The FDA product code for SURG-A-STAT LOOP TIP 2 is GEI.

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.

K841604ADJUST-A-TEMP HIGH TEMPERATUREK841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841603ADJUST-A-TEMP MICROK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841591PYRO-TIPK840376SURG-A STAT LOOP 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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