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FDA 510(k)

STERILE DISPOSABLE INSTRUMENT TRAYS

K-Number: K810004 · 1981-01-26

ApplicantAscep, Inc.
Decision Date1981-01-26
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE INSTRUMENT TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Ascep, Inc.. It received FDA 510(k) clearance on 1981-01-26 under 510(k) number K810004. 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 STERILE DISPOSABLE INSTRUMENT TRAYS?

STERILE DISPOSABLE INSTRUMENT TRAYS is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Ascep, Inc.. The 510(k) number is K810004.

When did STERILE DISPOSABLE INSTRUMENT TRAYS receive FDA 510(k) clearance?

STERILE DISPOSABLE INSTRUMENT TRAYS received FDA 510(k) clearance on 1981-01-26, under 510(k) number K810004.

Who is the listed applicant for STERILE DISPOSABLE INSTRUMENT TRAYS?

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

What is the FDA product code for STERILE DISPOSABLE INSTRUMENT TRAYS?

The FDA product code for STERILE DISPOSABLE INSTRUMENT TRAYS is FSM.

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Other records listing Ascep, 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.

K830219VARIOUS INSTRUMENTS & INSTRUMENT TRAYSK822893G.E.V. DISPOSABLE SCALPELSK802726INSTRUMENTS NONSTERILE & STERILEK791886I.V. CARE KITK791885I.V. START SETK791888CATHETER CARE KIT REORDER 7940&7941

View all 9 devices →

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

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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