FDA 510(k)

STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT

K-Number: K875280 · 1988-09-13

ApplicantSteris C/O Medical Device Consultants, Inc.

Decision Date1988-09-13

Product CodeMED

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT is the device name listed in this FDA 510(k) record. The listed applicant is Steris C/O Medical Device Consultants, Inc.. It received FDA 510(k) clearance on 1988-09-13 under 510(k) number K875280. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT?

STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is Steris C/O Medical Device Consultants, Inc.. The 510(k) number is K875280.

When did STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT receive FDA 510(k) clearance?

STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT received FDA 510(k) clearance on 1988-09-13, under 510(k) number K875280.

Who is the listed applicant for STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT?

The FDA 510(k) record lists Steris C/O Medical Device Consultants, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT?

The FDA product code for STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT is MED.

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Official Source

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