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FDA 510(k)

TELESCOPING PENEVAC

K-Number: K954088 · 1995-09-22

ApplicantI.C Medical, Inc.
Decision Date1995-09-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TELESCOPING PENEVAC is the device name listed in this FDA 510(k) record. The listed applicant is I.C Medical, Inc.. It received FDA 510(k) clearance on 1995-09-22 under 510(k) number K954088. 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 TELESCOPING PENEVAC?

TELESCOPING PENEVAC is a medical device that received FDA 510(k) clearance on 1995-09-22. The listed applicant is I.C Medical, Inc.. The 510(k) number is K954088.

When did TELESCOPING PENEVAC receive FDA 510(k) clearance?

TELESCOPING PENEVAC received FDA 510(k) clearance on 1995-09-22, under 510(k) number K954088.

Who is the listed applicant for TELESCOPING PENEVAC?

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

What is the FDA product code for TELESCOPING PENEVAC?

The FDA product code for TELESCOPING PENEVAC is GEI.

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Other records listing I.C Medical, 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.

K163659Crystal VisionK160160Non-Telescopic PenEvacK003840CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIESK960492SI CONTROLLER MODEL SI 500K961616TELESCOPING PENEVAC (MODIFICATION)K955166PENEVAC SI.

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Related Devices (Code: GEI)

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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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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