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FDA 510(k)

PHARMASEAL EYE PREP TRAY

K-Number: K850119 · 1985-05-09

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1985-05-09
Product CodeHNR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHARMASEAL EYE PREP 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 1985-05-09 under 510(k) number K850119. The device is classified under product code HNR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMASEAL EYE PREP TRAY?

PHARMASEAL EYE PREP TRAY is a medical device that received FDA 510(k) clearance on 1985-05-09. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K850119.

When did PHARMASEAL EYE PREP TRAY receive FDA 510(k) clearance?

PHARMASEAL EYE PREP TRAY received FDA 510(k) clearance on 1985-05-09, under 510(k) number K850119.

Who is the listed applicant for PHARMASEAL EYE PREP 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 PHARMASEAL EYE PREP TRAY?

The FDA product code for PHARMASEAL EYE PREP TRAY is HNR.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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Related Devices (Code: HNR)

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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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