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FDA 510(k)

VARIOUS DISPOSABLE KITS/TRAYS/INSTRU

K-Number: K840976 · 1984-05-31

ApplicantCarapace, Inc.
Decision Date1984-05-31
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VARIOUS DISPOSABLE KITS/TRAYS/INSTRU is the device name listed in this FDA 510(k) record. The listed applicant is Carapace, Inc.. It received FDA 510(k) clearance on 1984-05-31 under 510(k) number K840976. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIOUS DISPOSABLE KITS/TRAYS/INSTRU?

VARIOUS DISPOSABLE KITS/TRAYS/INSTRU is a medical device that received FDA 510(k) clearance on 1984-05-31. The listed applicant is Carapace, Inc.. The 510(k) number is K840976.

When did VARIOUS DISPOSABLE KITS/TRAYS/INSTRU receive FDA 510(k) clearance?

VARIOUS DISPOSABLE KITS/TRAYS/INSTRU received FDA 510(k) clearance on 1984-05-31, under 510(k) number K840976.

Who is the listed applicant for VARIOUS DISPOSABLE KITS/TRAYS/INSTRU?

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

What is the FDA product code for VARIOUS DISPOSABLE KITS/TRAYS/INSTRU?

The FDA product code for VARIOUS DISPOSABLE KITS/TRAYS/INSTRU is FSM.

Related Clinical Trials

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.

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Other records listing Carapace, 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.

K931722CARAPACE LABOR AND DELIVERY SETSK931822CARAPACE PELVIC EXAM TRAYSK931729I.V. START KITK931820CARAPACE STILLWATER BOWL SETK931669CARAPACE DEBRIDEMENT KITSK931760CARAPACE PACKING GAUZE TRAYS

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Related Devices (Code: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., Inc.

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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