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FDA 510(k)

SURG-A-STAT FINE TIP 2

K-Number: K840585 · 1984-04-23

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-04-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURG-A-STAT FINE 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 1984-04-23 under 510(k) number K840585. 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 FINE TIP 2?

SURG-A-STAT FINE TIP 2 is a medical device that received FDA 510(k) clearance on 1984-04-23. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K840585.

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

SURG-A-STAT FINE TIP 2 received FDA 510(k) clearance on 1984-04-23, under 510(k) number K840585.

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

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

Other records listing Suncoast Medical Manufacturers, Inc. as applicant

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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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