OH-HARRIS— 510(k) K801388

Name: FDA 510(k) clearance K801388
Creator: U.S. Food and Drug Administration
Published: 1980-07-28

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K801388 for OH-HARRIS, Substantially Equivalent on 1980-07-28. Applicant: Johnson & Johnson Professionals, Inc.. Device class: 1.

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code KIH
Device class: Class 1
Regulation: 21 CFR 888.4200
Advisory panel: Orthopedic
Date received: 1980-06-13
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIH

view all

K042591 — SMARTMIX PRE-FILLED MIXING SYSTEM2004-10-22
K943906 — P.F.C. CEMENT PRESSURIZING SYSTEM1994-12-21
K897134 — CMW CEMENT PRESSURISATION SYSTEM1990-03-02
K851881 — ORTHOPEADIC CEMENT DELIVERY SYSTEM1985-06-13
K840046 — PRESSURIZING/SCAVENGING ACRYLIC CEMENT1984-02-09

More clearances from Johnson & Johnson Professionals, Inc.

view all

K992173 — SIPHONGUARD CSF CONTROL DEVICE2000-04-07
K991413 — CODMAN ETHISORB DURA PATCH2000-03-13
K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT1999-07-09
K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER1998-12-18
K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)1998-12-04

Adverse events under product code KIH

product code KIH

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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