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FDA 510(k)

DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM

K-Number: K970721 · 1997-03-21

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1997-03-21
Product CodeMCY
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1997-03-21 under 510(k) number K970721. The device is classified under product code MCY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM?

DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-21. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K970721.

When did DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM receive FDA 510(k) clearance?

DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM received FDA 510(k) clearance on 1997-03-21, under 510(k) number K970721.

Who is the listed applicant for DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM?

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

What is the FDA product code for DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM?

The FDA product code for DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM is MCY.

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Other records listing Johnson & Johnson Medical, 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.

K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLEK982641ADVANCED NIBP MODULEK983362NU-GEL * WOUND DRESSINGK982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATEK974080CRITIKON SOFT BLOOD PRESSURE CUFFK980493I.V. CATHETER SYSTEM

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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.

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 & SonsK951476E-PACK PROCEDURE KITSETHICON, 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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