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FDA 510(k)

EF SYNERGY QUAD MODIFIED

K-Number: K910242 · 1991-03-05

ApplicantRemel Co.
Decision Date1991-03-05
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EF SYNERGY QUAD MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1991-03-05 under 510(k) number K910242. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EF SYNERGY QUAD MODIFIED?

EF SYNERGY QUAD MODIFIED is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is Remel Co.. The 510(k) number is K910242.

When did EF SYNERGY QUAD MODIFIED receive FDA 510(k) clearance?

EF SYNERGY QUAD MODIFIED received FDA 510(k) clearance on 1991-03-05, under 510(k) number K910242.

Who is the listed applicant for EF SYNERGY QUAD MODIFIED?

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

What is the FDA product code for EF SYNERGY QUAD MODIFIED?

The FDA product code for EF SYNERGY QUAD MODIFIED is JWY.

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Other records listing Remel Co. as applicant

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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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