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FDA 510(k)

INFUSA-PLATE(TM) EX

K-Number: K885083 · 1989-02-27

ApplicantKalayjian Ent.
Decision Date1989-02-27
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSA-PLATE(TM) EX is the device name listed in this FDA 510(k) record. The listed applicant is Kalayjian Ent.. It received FDA 510(k) clearance on 1989-02-27 under 510(k) number K885083. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSA-PLATE(TM) EX?

INFUSA-PLATE(TM) EX is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is Kalayjian Ent.. The 510(k) number is K885083.

When did INFUSA-PLATE(TM) EX receive FDA 510(k) clearance?

INFUSA-PLATE(TM) EX received FDA 510(k) clearance on 1989-02-27, under 510(k) number K885083.

Who is the listed applicant for INFUSA-PLATE(TM) EX?

The FDA 510(k) record lists Kalayjian Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFUSA-PLATE(TM) EX?

The FDA product code for INFUSA-PLATE(TM) EX is FRN.

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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.

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