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FDA 510(k)

COUNTERBORE FOR SS SUBMERGED SCREW PLANT

K-Number: K894150 · 1989-09-27

ApplicantArtech Corp.
Decision Date1989-09-27
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COUNTERBORE FOR SS SUBMERGED SCREW PLANT is the device name listed in this FDA 510(k) record. The listed applicant is Artech Corp.. It received FDA 510(k) clearance on 1989-09-27 under 510(k) number K894150. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COUNTERBORE FOR SS SUBMERGED SCREW PLANT?

COUNTERBORE FOR SS SUBMERGED SCREW PLANT is a medical device that received FDA 510(k) clearance on 1989-09-27. The listed applicant is Artech Corp.. The 510(k) number is K894150.

When did COUNTERBORE FOR SS SUBMERGED SCREW PLANT receive FDA 510(k) clearance?

COUNTERBORE FOR SS SUBMERGED SCREW PLANT received FDA 510(k) clearance on 1989-09-27, under 510(k) number K894150.

Who is the listed applicant for COUNTERBORE FOR SS SUBMERGED SCREW PLANT?

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

What is the FDA product code for COUNTERBORE FOR SS SUBMERGED SCREW PLANT?

The FDA product code for COUNTERBORE FOR SS SUBMERGED SCREW PLANT is DZJ.

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Other records listing Artech Corp. as applicant

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.

K911735ARTECH ARDENT IV - TYPE CLYLINDER IMPLANTK895267ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANTK891346ARTECH TYPE SS SUBMERGED SCREW IMPLANTK894160HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPLK894151IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANTK843217HOLLOW BASKET DENTAL IMPLANTS

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Related Devices (Code: DZJ)

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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