TECNOL PERSONAL SHOE COVER— 510(k) K861528

Substantially Equivalent

Technol, Inc.

FDA 510(k) clearance K861528 for TECNOL PERSONAL SHOE COVER, Substantially Equivalent on 1986-05-12. Applicant: Technol, Inc.. Device class: 1.

Clearance details

Applicant: Technol, Inc.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1986-04-24
Decision date: 1986-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FXP

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K961342 — SHOE COVER, NON-STERILE1996-12-30
K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH1996-11-19

More clearances from Technol, Inc.

K884132 — TECNOL BUCKS TRACTION W/HEEL PROTECTOR1988-10-11

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