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FDA 510(k)

SAFTI-BRACELET

K-Number: K853418 · 1985-09-20

ApplicantAdvanced Biosearch Assn.
Decision Date1985-09-20
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFTI-BRACELET is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biosearch Assn.. It received FDA 510(k) clearance on 1985-09-20 under 510(k) number K853418. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFTI-BRACELET?

SAFTI-BRACELET is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is Advanced Biosearch Assn.. The 510(k) number is K853418.

When did SAFTI-BRACELET receive FDA 510(k) clearance?

SAFTI-BRACELET received FDA 510(k) clearance on 1985-09-20, under 510(k) number K853418.

Who is the listed applicant for SAFTI-BRACELET?

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

What is the FDA product code for SAFTI-BRACELET?

The FDA product code for SAFTI-BRACELET is KMK.

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Other records listing Advanced Biosearch Assn. 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.

K905514AUTOGENESIS(TM) AUTOMATORK883888CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.K854770MARTIN LAMINAR OSTEOSYNTHESIS SYSTEMK855030CHAMPY BONE PLATES & BONE SCREWSK855031MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE PK853916P.M. HIP-FEMORAL PROSTHESIS

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Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K981860A P HARNESSParaworks Enterprise, Ltd.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K941098SECURE-SITEOp-Co Medical Products , Ltd.K943147STATLOCK CVVenetec, Inc.K943047IV START KITSSterile Concepts, 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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