Who is the manufacturer of BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM?

Johnson & Johnson International filed the 510(k) submission for BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (K895207).

What is the FDA product code for BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM?

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

What is the regulatory pathway for BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM?

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

Who can help prepare an FDA 510(k) submission like BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM?

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.

BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM

K895207 · Johnson & Johnson International · FRO · Sep 28, 1989 · SU

Device Facts

Record ID	K895207
Device Name	BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM
Applicant	Johnson & Johnson International
Product Code	FRO · SU
Decision Date	Sep 28, 1989
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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