Cleared Traditional

CAMPION LASER FORCEPS

K891348 · Simpson/Basye, Inc. · General & Plastic Surgery

Mar 1989

Decision

12d

Days

Class 1

Risk

About This 510(k) Submission

K891348 is an FDA 510(k) clearance for the CAMPION LASER FORCEPS, a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 22, 1989, 12 days after receiving the submission on March 10, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K891348 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 1989
Decision Date	March 22, 1989
Days to Decision	12 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—