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FDA 510(k)

VARIOUS INSTRUMENTS & INSTRUMENT TRAYS

K-Number: K830219 · 1983-04-12

ApplicantAscep, Inc.
Decision Date1983-04-12
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VARIOUS INSTRUMENTS & 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 1983-04-12 under 510(k) number K830219. 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 VARIOUS INSTRUMENTS & INSTRUMENT TRAYS?

VARIOUS INSTRUMENTS & INSTRUMENT TRAYS is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Ascep, Inc.. The 510(k) number is K830219.

When did VARIOUS INSTRUMENTS & INSTRUMENT TRAYS receive FDA 510(k) clearance?

VARIOUS INSTRUMENTS & INSTRUMENT TRAYS received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830219.

Who is the listed applicant for VARIOUS INSTRUMENTS & 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 VARIOUS INSTRUMENTS & INSTRUMENT TRAYS?

The FDA product code for VARIOUS INSTRUMENTS & 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.

K822893G.E.V. DISPOSABLE SCALPELSK810004STERILE DISPOSABLE INSTRUMENT TRAYSK802726INSTRUMENTS NONSTERILE & STERILEK791886I.V. CARE KITK791885I.V. START SETK791888CATHETER CARE KIT REORDER 7940&7941

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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

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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