FDA 510(k)

STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION

K-Number: K905846 · 1991-04-08

Decision Date1991-04-08

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION 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 1991-04-08 under 510(k) number K905846. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION?

STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-04-08. The listed applicant is Strato Medical Corp.. The 510(k) number is K905846.

When did STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION receive FDA 510(k) clearance?

STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION received FDA 510(k) clearance on 1991-04-08, under 510(k) number K905846.

Who is the listed applicant for STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION?

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 LOW PROFILE PORT(LPS 1055)/MODIFICATION?

The FDA product code for STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION is LJT.

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Other records listing Strato Medical Corp. as applicant

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Related Devices (Code: 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.