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FDA 510(k)

DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS

K-Number: K861525 · 1986-05-06

ApplicantD & D Products, Inc.
Decision Date1986-05-06
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS is the device name listed in this FDA 510(k) record. The listed applicant is D & D Products, Inc.. It received FDA 510(k) clearance on 1986-05-06 under 510(k) number K861525. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS?

DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS is a medical device that received FDA 510(k) clearance on 1986-05-06. The listed applicant is D & D Products, Inc.. The 510(k) number is K861525.

When did DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS receive FDA 510(k) clearance?

DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS received FDA 510(k) clearance on 1986-05-06, under 510(k) number K861525.

Who is the listed applicant for DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS?

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

What is the FDA product code for DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS?

The FDA product code for DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS is FSM.

Related Clinical Trials

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.

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Related Devices (Code: FSM)

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.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., Inc.

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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