FDA 510(k)

AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY

K-Number: K842542 · 1984-08-20

Decision Date1984-08-20

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1984-08-20 under 510(k) number K842542. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY?

AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY is a medical device that received FDA 510(k) clearance on 1984-08-20. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K842542.

When did AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY receive FDA 510(k) clearance?

AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY received FDA 510(k) clearance on 1984-08-20, under 510(k) number K842542.

Who is the listed applicant for AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY?

The FDA product code for AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY is FMI.

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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.