FDA 510(k)

STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED

K-Number: K905851 · 1991-04-05

Decision Date1991-04-05

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/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 1991-04-05 under 510(k) number K905851. 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 PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED?

STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED is a medical device that received FDA 510(k) clearance on 1991-04-05. The listed applicant is Strato Medical Corp.. The 510(k) number is K905851.

When did STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED receive FDA 510(k) clearance?

STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED received FDA 510(k) clearance on 1991-04-05, under 510(k) number K905851.

Who is the listed applicant for STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/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 W/PRE-ATTACH CATH(LPS 6015)/MODIFIED?

The FDA product code for STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/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.