Who is the manufacturer of CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE?

Beiersdorf, Inc. filed the 510(k) submission for CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE (K850147).

What is the FDA product code for CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE

K850147 · Beiersdorf, Inc. · FRO · Jul 5, 1985 · SU

Device Facts

Record ID	K850147
Device Name	CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
Applicant	Beiersdorf, Inc.
Product Code	FRO · SU
Decision Date	Jul 5, 1985
Decision	SN
Submission Type	Traditional
Device Class	Class U

Sort by

Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from the tree

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE

Device Facts

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE

Device Facts

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!