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FDA 510(k)

DISIMETRIC RELEASE OF INSTRANETICS RAD

K-Number: K830786 · 1983-05-18

ApplicantAmerican Convertors Div., American Pharmaseal
Decision Date1983-05-18
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISIMETRIC RELEASE OF INSTRANETICS RAD is the device name listed in this FDA 510(k) record. The listed applicant is American Convertors Div., American Pharmaseal. It received FDA 510(k) clearance on 1983-05-18 under 510(k) number K830786. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISIMETRIC RELEASE OF INSTRANETICS RAD?

DISIMETRIC RELEASE OF INSTRANETICS RAD is a medical device that received FDA 510(k) clearance on 1983-05-18. The listed applicant is American Convertors Div., American Pharmaseal. The 510(k) number is K830786.

When did DISIMETRIC RELEASE OF INSTRANETICS RAD receive FDA 510(k) clearance?

DISIMETRIC RELEASE OF INSTRANETICS RAD received FDA 510(k) clearance on 1983-05-18, under 510(k) number K830786.

Who is the listed applicant for DISIMETRIC RELEASE OF INSTRANETICS RAD?

The FDA 510(k) record lists American Convertors Div., American Pharmaseal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISIMETRIC RELEASE OF INSTRANETICS RAD?

The FDA product code for DISIMETRIC RELEASE OF INSTRANETICS RAD is KOA.

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Other records listing American Convertors Div., American Pharmaseal 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.

K840957ANTIMICROBIAL INCISE DRAPEK832137CONVERTORS FLASH STERILIZING TRAYK820994ABSORB FURN SHEETK813419COMFORT CUSHION DRY BURN PAD IIIK813296CONVERTORS STERILE DISP. LAP SPONGE IIK813078CONTURA DISPOS. SURG. FACE MASK

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Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K931181VESITEC SUTURE PASSERVesitec Medical, Inc.K921304DDV LIGATORNorth American Medical, 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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