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FDA 510(k)

5010 VISUSTIM

K-Number: K822919 · 1982-12-28

ApplicantLife-Tech Intl., Inc.
Decision Date1982-12-28
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

5010 VISUSTIM is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K822919. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5010 VISUSTIM?

5010 VISUSTIM is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K822919.

When did 5010 VISUSTIM receive FDA 510(k) clearance?

5010 VISUSTIM received FDA 510(k) clearance on 1982-12-28, under 510(k) number K822919.

Who is the listed applicant for 5010 VISUSTIM?

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

What is the FDA product code for 5010 VISUSTIM?

The FDA product code for 5010 VISUSTIM is HLX.

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Other records listing Life-Tech Intl., 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.

K001129PROLONG, MODELS PL50, PL100, PL150K955031MAXISTIMK954505EZ STIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

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Related Devices (Code: HLX)

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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