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FDA 510(k)

INCISION & DRAINAGE TRAY

K-Number: K812134 · 1982-01-15

ApplicantE.M. Adams
Decision Date1982-01-15
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INCISION & DRAINAGE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is E.M. Adams. It received FDA 510(k) clearance on 1982-01-15 under 510(k) number K812134. 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 INCISION & DRAINAGE TRAY?

INCISION & DRAINAGE TRAY is a medical device that received FDA 510(k) clearance on 1982-01-15. The listed applicant is E.M. Adams. The 510(k) number is K812134.

When did INCISION & DRAINAGE TRAY receive FDA 510(k) clearance?

INCISION & DRAINAGE TRAY received FDA 510(k) clearance on 1982-01-15, under 510(k) number K812134.

Who is the listed applicant for INCISION & DRAINAGE TRAY?

The FDA 510(k) record lists E.M. Adams as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INCISION & DRAINAGE TRAY?

The FDA product code for INCISION & DRAINAGE TRAY is FSM.

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Other records listing E.M. Adams 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.

K905173SPLASH GUARDK910468STERILE DISPOSABLE DRAPE(S)K873978DISPOSABLE BIPOLAR FORCEPSK850063INSTRUMENT POCKETK843724I.V. START KIT & OBSTETRICAL KITK843783WET PACK

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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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