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FDA 510(k)

SYRETTE

K-Number: K881992 · 1988-07-26

ApplicantOratec Corp.
Decision Date1988-07-26
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYRETTE is the device name listed in this FDA 510(k) record. The listed applicant is Oratec Corp.. It received FDA 510(k) clearance on 1988-07-26 under 510(k) number K881992. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRETTE?

SYRETTE is a medical device that received FDA 510(k) clearance on 1988-07-26. The listed applicant is Oratec Corp.. The 510(k) number is K881992.

When did SYRETTE receive FDA 510(k) clearance?

SYRETTE received FDA 510(k) clearance on 1988-07-26, under 510(k) number K881992.

Who is the listed applicant for SYRETTE?

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

What is the FDA product code for SYRETTE?

The FDA product code for SYRETTE is EKJ.

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Related Devices (Code: EKJ)

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.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, Inc.

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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