VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.— 510(k) K770428

Name: FDA 510(k) clearance K770428
Creator: U.S. Food and Drug Administration
Published: 1979-09-12

Substantially Equivalent

Holco Instrument Corp.

FDA 510(k) clearance K770428 for VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC., Substantially Equivalent on 1979-09-12. Applicant: Holco Instrument Corp.. Device class: 1.

Clearance details

Applicant: Holco Instrument Corp.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1977-03-07
Decision date: 1979-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K761324 — RESURFACE PROSTHESES FOR HIP JOINT1977-01-05

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.