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FDA 510(k)

CONTRAST BACKGROUND MATERIAL

K-Number: K895681 · 1989-10-24

ApplicantApplied Medical Technologies
Decision Date1989-10-24
Product CodeGAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONTRAST BACKGROUND MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technologies. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K895681. The device is classified under product code GAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTRAST BACKGROUND MATERIAL?

CONTRAST BACKGROUND MATERIAL is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Applied Medical Technologies. The 510(k) number is K895681.

When did CONTRAST BACKGROUND MATERIAL receive FDA 510(k) clearance?

CONTRAST BACKGROUND MATERIAL received FDA 510(k) clearance on 1989-10-24, under 510(k) number K895681.

Who is the listed applicant for CONTRAST BACKGROUND MATERIAL?

The FDA 510(k) record lists Applied Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTRAST BACKGROUND MATERIAL?

The FDA product code for CONTRAST BACKGROUND MATERIAL is GAB.

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Other records listing Applied Medical Technologies 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.

K971434A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICEK972478PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIESK973893AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAEK971757LOW PROFILE FEEDING SET ACCESSORYK971758CAUTERIZATION SMOKE EVACUATORK961345DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE

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Related Devices (Code: GAB)

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.

K012199DIGICAPHumana USA, Inc.K980988AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)Axya Medical, Inc.K932591ENDO-JUDGESynergistic Medical Technologies, Inc.K863595COATED SUTURE NEEDLESharpoint, Inc.K831648ANCHOR BRAND SURGICAL NEEDLESAnchor Products Co.K812444RADIATION STERILIZATION FOR NEEDLE CNTRDevon Industries, 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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