SORBOTHANE— 510(k) K810228

Substantially Equivalent

Hamilton Kent

FDA 510(k) clearance K810228 for SORBOTHANE, Substantially Equivalent on 1981-02-10. Applicant: Hamilton Kent. Device class: 1.

Clearance details

Applicant: Hamilton Kent
Product code: Code KNP
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 1981-01-27
Decision date: 1981-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNP

K831690 — IPOS ANTI-ADDUCTUS SHOE1983-06-24
K831552 — SORBOTHANE VISCO INNER SOLE PAD1983-06-08
K823654 — SLIP-ON SANDALS FOR MEASURING SHORTNESS1983-01-21
K823665 — ROTATION BOOT1982-12-30
K801743 — PLASTAZOTE SHOE1980-08-07

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