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FDA 510(k)

REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178

K-Number: K892424 · 1989-06-09

ApplicantHelena Laboratories
Decision Date1989-06-09
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K892424. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178?

REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Helena Laboratories. The 510(k) number is K892424.

When did REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 receive FDA 510(k) clearance?

REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 received FDA 510(k) clearance on 1989-06-09, under 510(k) number K892424.

Who is the listed applicant for REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178?

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 REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178?

The FDA product code for REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 is CFF.

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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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