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FDA 510(k)

KAPTON PEEL POUCH

K-Number: K933228 · 1994-03-30

ApplicantAmerican Fluoroseal Corp.
Decision Date1994-03-30
Product CodeKJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KAPTON PEEL POUCH is the device name listed in this FDA 510(k) record. The listed applicant is American Fluoroseal Corp.. It received FDA 510(k) clearance on 1994-03-30 under 510(k) number K933228. The device is classified under product code KJA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAPTON PEEL POUCH?

KAPTON PEEL POUCH is a medical device that received FDA 510(k) clearance on 1994-03-30. The listed applicant is American Fluoroseal Corp.. The 510(k) number is K933228.

When did KAPTON PEEL POUCH receive FDA 510(k) clearance?

KAPTON PEEL POUCH received FDA 510(k) clearance on 1994-03-30, under 510(k) number K933228.

Who is the listed applicant for KAPTON PEEL POUCH?

The FDA 510(k) record lists American Fluoroseal Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KAPTON PEEL POUCH?

The FDA product code for KAPTON PEEL POUCH is KJA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Fluoroseal Corp. 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.

K870865TISSUE CULTURE BAG

Related Devices (Code: KJA)

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.

K972404VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)Bd Becton Dickinson Vacutainer Systems PreanalyticK885121CELL SCRAPERBd Becton Dickinson Vacutainer Systems PreanalyticK873889TISSUE CULTURE TUBESNunc, Inc.K873890TISSUE CULTURE FLASKSNunc, Inc.K871324DU PONT STERICELL CELL CULTURE SYSTEME.I. Dupont DE Nemours & Co., Inc.K870865TISSUE CULTURE BAGAmerican Fluoroseal Corp.

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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