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FDA 510(k)

PROPOSED CONTROLS FOR DOSIMETRIC RELEASE

K-Number: K812068 · 1981-09-08

ApplicantHexcel Medical
Decision Date1981-09-08
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROPOSED CONTROLS FOR DOSIMETRIC RELEASE is the device name listed in this FDA 510(k) record. The listed applicant is Hexcel Medical. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812068. The device is classified under product code LIB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPOSED CONTROLS FOR DOSIMETRIC RELEASE?

PROPOSED CONTROLS FOR DOSIMETRIC RELEASE is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Hexcel Medical. The 510(k) number is K812068.

When did PROPOSED CONTROLS FOR DOSIMETRIC RELEASE receive FDA 510(k) clearance?

PROPOSED CONTROLS FOR DOSIMETRIC RELEASE received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812068.

Who is the listed applicant for PROPOSED CONTROLS FOR DOSIMETRIC RELEASE?

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

What is the FDA product code for PROPOSED CONTROLS FOR DOSIMETRIC RELEASE?

The FDA product code for PROPOSED CONTROLS FOR DOSIMETRIC RELEASE is LIB.

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Other records listing Hexcel Medical 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.

K840416HEXCELITEK820890URETHANE ORTHOPAEDIC CASTING TAPEK812687BRIGHAM II TOTAL HIP SYSTEMK812669SEATTLE II TOTAL HIP SYSTEMK811164URETHANE ORTHOPAEDIC CASTING TAPEK810957MARCOVE INTRAMEDULLARY ROD

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Related Devices (Code: LIB)

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.

K023677OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)OsmetechK920416SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMBBehring Diagnostics, Inc.K912558GULL ELISAWAREGull Laboratories, Inc.K872273CORNING EASY WASH ELISA PLATESCorning Medical & ScientificK871559CELL LIFTERCorning Costar Corp.K864249NORMAL SALINE STERILEMds Laboratories, 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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