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FDA 510(k)

PROPHYLACTIC

K-Number: K772181 · 1977-12-20

ApplicantOm Industries, Inc.
Decision Date1977-12-20
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PROPHYLACTIC is the device name listed in this FDA 510(k) record. The listed applicant is Om Industries, Inc.. It received FDA 510(k) clearance on 1977-12-20 under 510(k) number K772181. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPHYLACTIC?

PROPHYLACTIC is a medical device that received FDA 510(k) clearance on 1977-12-20. The listed applicant is Om Industries, Inc.. The 510(k) number is K772181.

When did PROPHYLACTIC receive FDA 510(k) clearance?

PROPHYLACTIC received FDA 510(k) clearance on 1977-12-20, under 510(k) number K772181.

Who is the listed applicant for PROPHYLACTIC?

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

What is the FDA product code for PROPHYLACTIC?

The FDA product code for PROPHYLACTIC is HIS.

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Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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