Cleared Traditional

VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS

K895920 · Vitaphore Corp. · General & Plastic Surgery

Jun 1991

Decision

603d

Days

Class 1

Risk

About This 510(k) Submission

K895920 is an FDA 510(k) clearance for the VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on June 6, 1991, 603 days after receiving the submission on October 11, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number	K895920 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 1989
Decision Date	June 06, 1991
Days to Decision	603 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—