Who is the manufacturer of SCANLAN (TM) VEIN/GRAFT HOLDER?

Scanlan Intl., Inc. filed the 510(k) submission for SCANLAN (TM) VEIN/GRAFT HOLDER (K864919).

What is the FDA product code for SCANLAN (TM) VEIN/GRAFT HOLDER?

KPK. It is classified under 21 CFR 878.4650 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for SCANLAN (TM) VEIN/GRAFT HOLDER?

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

Who can help prepare an FDA 510(k) submission like SCANLAN (TM) VEIN/GRAFT HOLDER?

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.

SCANLAN (TM) VEIN/GRAFT HOLDER

K864919 · Scanlan Intl., Inc. · KPK · Jan 12, 1987 · General, Plastic Surgery

Device Facts

Record ID	K864919
Device Name	SCANLAN (TM) VEIN/GRAFT HOLDER
Applicant	Scanlan Intl., Inc.
Product Code	KPK · General, Plastic Surgery
Decision Date	Jan 12, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4650
Device Class	Class 2

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