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FDA 510(k)

SYRINGE INJECTION GUN DELIVERY KITS

K-Number: K890658 · 1989-10-03

ApplicantGastrotech, Inc.
Decision Date1989-10-03
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYRINGE INJECTION GUN DELIVERY KITS is the device name listed in this FDA 510(k) record. The listed applicant is Gastrotech, Inc.. It received FDA 510(k) clearance on 1989-10-03 under 510(k) number K890658. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRINGE INJECTION GUN DELIVERY KITS?

SYRINGE INJECTION GUN DELIVERY KITS is a medical device that received FDA 510(k) clearance on 1989-10-03. The listed applicant is Gastrotech, Inc.. The 510(k) number is K890658.

When did SYRINGE INJECTION GUN DELIVERY KITS receive FDA 510(k) clearance?

SYRINGE INJECTION GUN DELIVERY KITS received FDA 510(k) clearance on 1989-10-03, under 510(k) number K890658.

Who is the listed applicant for SYRINGE INJECTION GUN DELIVERY KITS?

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

What is the FDA product code for SYRINGE INJECTION GUN DELIVERY KITS?

The FDA product code for SYRINGE INJECTION GUN DELIVERY KITS is LRO.

Related Clinical Trials

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.

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Other records listing Gastrotech, 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.

K890629ESOPHAGEAL OVERTUBEK883351PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBEK883336GASTROSTOMY FEEDING TUBEK862853SYRINGE INJECTION GUN

Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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