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FDA 510(k)

TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE

K-Number: K973062 · 1997-10-09

ApplicantMedidenta Intl., Inc.
Decision Date1997-10-09
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE is the device name listed in this FDA 510(k) record. The listed applicant is Medidenta Intl., Inc.. It received FDA 510(k) clearance on 1997-10-09 under 510(k) number K973062. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE?

TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE is a medical device that received FDA 510(k) clearance on 1997-10-09. The listed applicant is Medidenta Intl., Inc.. The 510(k) number is K973062.

When did TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE receive FDA 510(k) clearance?

TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE received FDA 510(k) clearance on 1997-10-09, under 510(k) number K973062.

Who is the listed applicant for TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE?

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

What is the FDA product code for TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE?

The FDA product code for TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE is EFA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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