BOWEN KNOT PASSER— 510(k) K863148

Substantially Equivalent

Bowen & Company, Inc.

FDA 510(k) clearance K863148 for BOWEN KNOT PASSER, Substantially Equivalent on 1986-09-05. Applicant: Bowen & Company, Inc.. Device class: 1.

Clearance details

Applicant: Bowen & Company, Inc.
Product code: Code HXI
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1986-08-15
Decision date: 1986-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXI

K140576 — Y WIRE 22014-05-20
K863146 — BOWEN SUTURE PASSER1986-09-05

More clearances from Bowen & Company, Inc.

K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER1990-04-04
K896538 — DISPOSABLE 45 DEGREE SHAVER1989-12-06
K873766 — STERNAL POWER AWL1988-11-14
K872098 — CREMEEN ALVEOLAR BONE CALIPER1987-07-31
K871325 — BOWEN REUSEABLE/DISPOSABLE ELECTRODE1987-06-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.