FDA 510(k)

STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED

K-Number: K905852 · 1991-04-19

Decision Date1991-04-19

Product CodeLJT

Advisory CommitteeHO

DecisionUnknown

Device Summary

STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Strato Medical Corp.. It received FDA 510(k) clearance on 1991-04-19 under 510(k) number K905852. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED?

STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED is a medical device that received FDA 510(k) clearance on 1991-04-19. The listed applicant is Strato Medical Corp.. The 510(k) number is K905852.

When did STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED receive FDA 510(k) clearance?

STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED received FDA 510(k) clearance on 1991-04-19, under 510(k) number K905852.

Who is the listed applicant for STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED?

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

What is the FDA product code for STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED?

The FDA product code for STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED is LJT.

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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.