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FDA 510(k)

GAMMA RADIATION STERILIZATION PRECEDURE

K-Number: K781668 · 1978-11-03

ApplicantCutter Laboratories, Inc.
Decision Date1978-11-03
Product CodeKYJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAMMA RADIATION STERILIZATION PRECEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781668. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA RADIATION STERILIZATION PRECEDURE?

GAMMA RADIATION STERILIZATION PRECEDURE is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K781668.

When did GAMMA RADIATION STERILIZATION PRECEDURE receive FDA 510(k) clearance?

GAMMA RADIATION STERILIZATION PRECEDURE received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781668.

Who is the listed applicant for GAMMA RADIATION STERILIZATION PRECEDURE?

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

What is the FDA product code for GAMMA RADIATION STERILIZATION PRECEDURE?

The FDA product code for GAMMA RADIATION STERILIZATION PRECEDURE is KYJ.

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Other records listing Cutter Laboratories, 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.

K861315HYPERBARIC PENETRATION EXTENSION SETK854106BAYSILEXK842324PERFOURMK834106INTRAVENOUS INFUSION CONTROLLERK832237ORTHOPEDIC CASTING TAPE MAXCASTK823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SET

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Related Devices (Code: KYJ)

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.

K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc.K220142BRM Digitalis SpacerBrm Extremities SrlK211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SAK083107MODIFICATION TO DEPUY NEUFLEX PIP FINGERDePuy Orthopaedics, Inc.K082231ASCENSION SILICONE PIPAscension Orthopedics, Inc.K022892ASCENSION SILLICONE MCPAscension Orthopedics, 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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