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FDA 510(k)

CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER

K-Number: K921347 · 1993-01-08

ApplicantMedi-Flex Hospital Products, Inc.
Decision Date1993-01-08
Product CodeMCY
Advisory CommitteeHO
DecisionUnknown

Device Summary

CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Flex Hospital Products, Inc.. It received FDA 510(k) clearance on 1993-01-08 under 510(k) number K921347. The device is classified under product code MCY. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER?

CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER is a medical device that received FDA 510(k) clearance on 1993-01-08. The listed applicant is Medi-Flex Hospital Products, Inc.. The 510(k) number is K921347.

When did CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER receive FDA 510(k) clearance?

CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER received FDA 510(k) clearance on 1993-01-08, under 510(k) number K921347.

Who is the listed applicant for CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER?

The FDA 510(k) record lists Medi-Flex Hospital Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER?

The FDA product code for CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER is MCY.

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Other records listing Medi-Flex Hospital Products, Inc. as applicant

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Related Devices (Code: MCY)

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.

K970721DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEMJohnson & Johnson Medical, Inc.K963719CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAYGrand Medical ProductsK960585WOUND CARE COMPRESSION SYSTEM (WCCS)Suncoast Medical Products, Inc.K952334DRESSING CHANGE TRAYBusse Hospital Disposables, Inc.K951022CIRCULON SYSTEM STEP 1Convatec, A Division of E.R. Squibb & SonsK951021CIRCULON SYSTEM STEP 2Convatec, A Division of E.R. Squibb & Sons

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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