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FDA 510(k)

A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)

K-Number: K897195 · 1990-05-31

ApplicantA Company, Inc.
Decision Date1990-05-31
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) is the device name listed in this FDA 510(k) record. The listed applicant is A Company, Inc.. It received FDA 510(k) clearance on 1990-05-31 under 510(k) number K897195. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)?

A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) is a medical device that received FDA 510(k) clearance on 1990-05-31. The listed applicant is A Company, Inc.. The 510(k) number is K897195.

When did A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) receive FDA 510(k) clearance?

A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) received FDA 510(k) clearance on 1990-05-31, under 510(k) number K897195.

Who is the listed applicant for A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)?

The FDA 510(k) record lists A Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)?

The FDA product code for A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) is EKS.

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Other records listing A Company, Inc. 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.

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Related Devices (Code: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.

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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