CARERITE & COST RITE NYLON STERILIZATION FILM— 510(k) K870147

Name: FDA 510(k) clearance K870147
Creator: U.S. Food and Drug Administration
Published: 1987-04-23

Substantially Equivalent

Cost Rite Health Products, Inc.

FDA 510(k) clearance K870147 for CARERITE & COST RITE NYLON STERILIZATION FILM, Substantially Equivalent on 1987-04-23. Applicant: Cost Rite Health Products, Inc.. Device class: 2.

Clearance details

Applicant: Cost Rite Health Products, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1987-01-13
Decision date: 1987-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodland Hills, CA, US

Download summary PDF View on FDA.gov ↗

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K871798 — FILM AND PAPER COMBINATION STERILIZING BAG1987-07-21
K871736 — CARERITE BIOPACK GINGIVAL RETRACTION CORD1987-05-27

Adverse events under product code FRG

product code FRG

Other: 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.