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FDA 510(k)

STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.

K-Number: K802634 · 1980-12-11

ApplicantOrganon, Inc.
Decision Date1980-12-11
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802634. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.?

STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Organon, Inc.. The 510(k) number is K802634.

When did STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. receive FDA 510(k) clearance?

STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802634.

Who is the listed applicant for STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.?

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

What is the FDA product code for STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.?

The FDA product code for STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. is JOJ.

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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.

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