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FDA 510(k)

BAND SEATER

K-Number: K951776 · 1995-05-23

ApplicantOrmco Corp.
Decision Date1995-05-23
Product CodeECR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BAND SEATER is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1995-05-23 under 510(k) number K951776. The device is classified under product code ECR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAND SEATER?

BAND SEATER is a medical device that received FDA 510(k) clearance on 1995-05-23. The listed applicant is Ormco Corp.. The 510(k) number is K951776.

When did BAND SEATER receive FDA 510(k) clearance?

BAND SEATER received FDA 510(k) clearance on 1995-05-23, under 510(k) number K951776.

Who is the listed applicant for BAND SEATER?

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 BAND SEATER?

The FDA product code for BAND SEATER is ECR.

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Related Devices (Code: ECR)

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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