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FDA 510(k)

ADT DISPOSABLE SCALPEL W/STAINLESS STEEL

K-Number: K830745 · 1983-04-12

ApplicantLab Industries, Inc.
Decision Date1983-04-12
Product CodeGDX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADT DISPOSABLE SCALPEL W/STAINLESS STEEL is the device name listed in this FDA 510(k) record. The listed applicant is Lab Industries, Inc.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830745. The device is classified under product code GDX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADT DISPOSABLE SCALPEL W/STAINLESS STEEL?

ADT DISPOSABLE SCALPEL W/STAINLESS STEEL is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Lab Industries, Inc.. The 510(k) number is K830745.

When did ADT DISPOSABLE SCALPEL W/STAINLESS STEEL receive FDA 510(k) clearance?

ADT DISPOSABLE SCALPEL W/STAINLESS STEEL received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830745.

Who is the listed applicant for ADT DISPOSABLE SCALPEL W/STAINLESS STEEL?

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

What is the FDA product code for ADT DISPOSABLE SCALPEL W/STAINLESS STEEL?

The FDA product code for ADT DISPOSABLE SCALPEL W/STAINLESS STEEL is GDX.

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Other records listing Lab Industries, Inc. as applicant

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Related Devices (Code: GDX)

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.

K923689SURGISTAR BLADESSurgistar, Inc.K921167ULTRABLADEMicron Technology, Inc.K914086ICAN CYLINDRICAL SPONGESIcn Pharmaceuticals, Inc.K904505CCI CORNEAL SCARIFIERBuckman Co., Inc.K9053801-CUT ACL GRAFT KNIFEDepuy, Inc.K895682VESSEL LOOPSApplied Medical Technologies

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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