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FDA 510(k)

TITAN GEL REP CPK-12 HV

K-Number: K874146 · 1987-11-05

ApplicantHelena Laboratories
Decision Date1987-11-05
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TITAN GEL REP CPK-12 HV is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-11-05 under 510(k) number K874146. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GEL REP CPK-12 HV?

TITAN GEL REP CPK-12 HV is a medical device that received FDA 510(k) clearance on 1987-11-05. The listed applicant is Helena Laboratories. The 510(k) number is K874146.

When did TITAN GEL REP CPK-12 HV receive FDA 510(k) clearance?

TITAN GEL REP CPK-12 HV received FDA 510(k) clearance on 1987-11-05, under 510(k) number K874146.

Who is the listed applicant for TITAN GEL REP CPK-12 HV?

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

What is the FDA product code for TITAN GEL REP CPK-12 HV?

The FDA product code for TITAN GEL REP CPK-12 HV is CGS.

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Related Devices (Code: CGS)

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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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