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FDA 510(k)

VERIFORM II

K-Number: K833583 · 1984-01-30

ApplicantAmerican Medical Systems, Inc.
Decision Date1984-01-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VERIFORM II is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K833583. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIFORM II?

VERIFORM II is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K833583.

When did VERIFORM II receive FDA 510(k) clearance?

VERIFORM II received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833583.

Who is the listed applicant for VERIFORM II?

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

What is the FDA product code for VERIFORM II?

The FDA product code for VERIFORM II is DXN.

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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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