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FDA 510(k)

SENTEC LASER GUIDE LINE, MODEL SGL-05

K-Number: K862340 · 1986-07-11

ApplicantSentec Corp.
Decision Date1986-07-11
Product CodeIZW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENTEC LASER GUIDE LINE, MODEL SGL-05 is the device name listed in this FDA 510(k) record. The listed applicant is Sentec Corp.. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K862340. The device is classified under product code IZW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTEC LASER GUIDE LINE, MODEL SGL-05?

SENTEC LASER GUIDE LINE, MODEL SGL-05 is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Sentec Corp.. The 510(k) number is K862340.

When did SENTEC LASER GUIDE LINE, MODEL SGL-05 receive FDA 510(k) clearance?

SENTEC LASER GUIDE LINE, MODEL SGL-05 received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862340.

Who is the listed applicant for SENTEC LASER GUIDE LINE, MODEL SGL-05?

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

What is the FDA product code for SENTEC LASER GUIDE LINE, MODEL SGL-05?

The FDA product code for SENTEC LASER GUIDE LINE, MODEL SGL-05 is IZW.

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Related Devices (Code: IZW)

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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