FDA 510(k)

STERRAD 100 STERILIZATION SYSTEM

K-Number: K915682 · 1993-10-01

ApplicantJohnson & Johnson Medical, Inc.

Decision Date1993-10-01

Product CodeFLF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERRAD 100 STERILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1993-10-01 under 510(k) number K915682. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERRAD 100 STERILIZATION SYSTEM?

STERRAD 100 STERILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 1993-10-01. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K915682.

When did STERRAD 100 STERILIZATION SYSTEM receive FDA 510(k) clearance?

STERRAD 100 STERILIZATION SYSTEM received FDA 510(k) clearance on 1993-10-01, under 510(k) number K915682.

Who is the listed applicant for STERRAD 100 STERILIZATION SYSTEM?

The FDA 510(k) record lists Johnson & Johnson Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERRAD 100 STERILIZATION SYSTEM?

The FDA product code for STERRAD 100 STERILIZATION SYSTEM is FLF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.