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FDA 510(k)

SURGICAL SEALANT APPLICATOR

K-Number: K883338 · 1988-08-23

ApplicantMicromedics, Inc.
Decision Date1988-08-23
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGICAL SEALANT APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc.. It received FDA 510(k) clearance on 1988-08-23 under 510(k) number K883338. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL SEALANT APPLICATOR?

SURGICAL SEALANT APPLICATOR is a medical device that received FDA 510(k) clearance on 1988-08-23. The listed applicant is Micromedics, Inc.. The 510(k) number is K883338.

When did SURGICAL SEALANT APPLICATOR receive FDA 510(k) clearance?

SURGICAL SEALANT APPLICATOR received FDA 510(k) clearance on 1988-08-23, under 510(k) number K883338.

Who is the listed applicant for SURGICAL SEALANT APPLICATOR?

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

What is the FDA product code for SURGICAL SEALANT APPLICATOR?

The FDA product code for SURGICAL SEALANT APPLICATOR is KYZ.

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Other records listing Micromedics, 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.

K241739Endoscopic Applicator, 41 cmK123847MALLEABLE TIP ENDOSCOPIC APPLICATORK122526360 GAS ASSISTED ENDOSCOPIC APPLICATORK120608ENDOSCOPIC APPLICATORK102563SINGLE CANNULA EXTENDED APPLICATORK100754GRAFT DELIVERY SYSTEM MODEL SA-6115

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Related Devices (Code: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, 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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