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FDA 510(k)

ORMCO SYSTEM 1+ (TM)

K-Number: K941015 · 1994-03-31

ApplicantOrmco Corp.
Decision Date1994-03-31
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORMCO SYSTEM 1+ (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1994-03-31 under 510(k) number K941015. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORMCO SYSTEM 1+ (TM)?

ORMCO SYSTEM 1+ (TM) is a medical device that received FDA 510(k) clearance on 1994-03-31. The listed applicant is Ormco Corp.. The 510(k) number is K941015.

When did ORMCO SYSTEM 1+ (TM) receive FDA 510(k) clearance?

ORMCO SYSTEM 1+ (TM) received FDA 510(k) clearance on 1994-03-31, under 510(k) number K941015.

Who is the listed applicant for ORMCO SYSTEM 1+ (TM)?

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

What is the FDA product code for ORMCO SYSTEM 1+ (TM)?

The FDA product code for ORMCO SYSTEM 1+ (TM) is DYH.

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Other records listing Ormco Corp. as applicant

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Related Devices (Code: DYH)

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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