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FDA 510(k)

TRISACRYL GF 05 & TRISACRYL GF 2000

K-Number: K840985 · 1984-04-19

ApplicantLkb Instruments, Inc.
Decision Date1984-04-19
Product CodeDJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRISACRYL GF 05 & TRISACRYL GF 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1984-04-19 under 510(k) number K840985. The device is classified under product code DJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRISACRYL GF 05 & TRISACRYL GF 2000?

TRISACRYL GF 05 & TRISACRYL GF 2000 is a medical device that received FDA 510(k) clearance on 1984-04-19. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K840985.

When did TRISACRYL GF 05 & TRISACRYL GF 2000 receive FDA 510(k) clearance?

TRISACRYL GF 05 & TRISACRYL GF 2000 received FDA 510(k) clearance on 1984-04-19, under 510(k) number K840985.

Who is the listed applicant for TRISACRYL GF 05 & TRISACRYL GF 2000?

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

What is the FDA product code for TRISACRYL GF 05 & TRISACRYL GF 2000?

The FDA product code for TRISACRYL GF 05 & TRISACRYL GF 2000 is DJY.

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Other records listing Lkb Instruments, Inc. as applicant

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Related Devices (Code: DJY)

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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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