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FDA 510(k)

BRACE (ORAFIX SPECIAL)

K-Number: K890290 · 1989-03-29

ApplicantNorcliff Thayer, Inc.
Decision Date1989-03-29
Product CodeECB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRACE (ORAFIX SPECIAL) is the device name listed in this FDA 510(k) record. The listed applicant is Norcliff Thayer, Inc.. It received FDA 510(k) clearance on 1989-03-29 under 510(k) number K890290. The device is classified under product code ECB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRACE (ORAFIX SPECIAL)?

BRACE (ORAFIX SPECIAL) is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Norcliff Thayer, Inc.. The 510(k) number is K890290.

When did BRACE (ORAFIX SPECIAL) receive FDA 510(k) clearance?

BRACE (ORAFIX SPECIAL) received FDA 510(k) clearance on 1989-03-29, under 510(k) number K890290.

Who is the listed applicant for BRACE (ORAFIX SPECIAL)?

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

What is the FDA product code for BRACE (ORAFIX SPECIAL)?

The FDA product code for BRACE (ORAFIX SPECIAL) is ECB.

Related Clinical Trials

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Other records listing Norcliff Thayer, 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: ECB)

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.

K942519UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPSBull Frog Mfg. Co.K931772SURETIP SYRINGE TIP COVERWestern M/D, Inc.K931137DENTAL SYRINGE TIPA-Dec, Inc.K923876RISKONTROL SINGLE USERiskontrolK923285PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLESmith & Nephew, Inc.K920499SANI-TIPDw Industries, 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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