Who is the manufacturer of NON-ADHERING DRESSING WITH POVIDONE-IODINE?

Johnson & Johnson Professionals, Inc. filed the 510(k) submission for NON-ADHERING DRESSING WITH POVIDONE-IODINE (K861384).

What is the FDA product code for NON-ADHERING DRESSING WITH POVIDONE-IODINE?

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

What is the regulatory pathway for NON-ADHERING DRESSING WITH POVIDONE-IODINE?

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

Who can help prepare an FDA 510(k) submission like NON-ADHERING DRESSING WITH POVIDONE-IODINE?

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.

NON-ADHERING DRESSING WITH POVIDONE-IODINE

K861384 · Johnson & Johnson Professionals, Inc. · FRO · Jul 1, 1986 · SU

Device Facts

Record ID	K861384
Device Name	NON-ADHERING DRESSING WITH POVIDONE-IODINE
Applicant	Johnson & Johnson Professionals, Inc.
Product Code	FRO · SU
Decision Date	Jul 1, 1986
Decision	SN
Submission Type	Traditional
Device Class	Class U

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