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FDA 510(k)

HEMOSLEEVE, MODEL 4.0MM, 5.5MM

K-Number: K984018 · 1999-03-15

ApplicantSurgical Laser Technologies, Inc.
Decision Date1999-03-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEMOSLEEVE, MODEL 4.0MM, 5.5MM is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Laser Technologies, Inc.. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K984018. 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 HEMOSLEEVE, MODEL 4.0MM, 5.5MM?

HEMOSLEEVE, MODEL 4.0MM, 5.5MM is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K984018.

When did HEMOSLEEVE, MODEL 4.0MM, 5.5MM receive FDA 510(k) clearance?

HEMOSLEEVE, MODEL 4.0MM, 5.5MM received FDA 510(k) clearance on 1999-03-15, under 510(k) number K984018.

Who is the listed applicant for HEMOSLEEVE, MODEL 4.0MM, 5.5MM?

The FDA 510(k) record lists Surgical Laser Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOSLEEVE, MODEL 4.0MM, 5.5MM?

The FDA product code for HEMOSLEEVE, MODEL 4.0MM, 5.5MM is GEI.

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Related Devices (Code: GEI)

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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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