FDA 510(k)

MALIS CMC-II BIPOLAR COAGULATOR & CUT

K-Number: K831508 · 1983-06-24

Decision Date1983-06-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MALIS CMC-II BIPOLAR COAGULATOR & CUT is the device name listed in this FDA 510(k) record. The listed applicant is Valley Forge Scientific Corp.. It received FDA 510(k) clearance on 1983-06-24 under 510(k) number K831508. 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 MALIS CMC-II BIPOLAR COAGULATOR & CUT?

MALIS CMC-II BIPOLAR COAGULATOR & CUT is a medical device that received FDA 510(k) clearance on 1983-06-24. The listed applicant is Valley Forge Scientific Corp.. The 510(k) number is K831508.

When did MALIS CMC-II BIPOLAR COAGULATOR & CUT receive FDA 510(k) clearance?

MALIS CMC-II BIPOLAR COAGULATOR & CUT received FDA 510(k) clearance on 1983-06-24, under 510(k) number K831508.

Who is the listed applicant for MALIS CMC-II BIPOLAR COAGULATOR & CUT?

The FDA 510(k) record lists Valley Forge Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MALIS CMC-II BIPOLAR COAGULATOR & CUT?

The FDA product code for MALIS CMC-II BIPOLAR COAGULATOR & CUT is GEI.

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Other records listing Valley Forge Scientific Corp. as applicant

K050364MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM K042604VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS K032601STRYKER INTERVENTIONAL PAIN RF GENERATOR K033499MALIS IRRIGATION MODULE 1000 K982229BI-DENT K973554VALLEY FORGE BIPOLAR BALL TIP ELECTRODE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.