ROTATION BOOT— 510(k) K823665

Name: FDA 510(k) clearance K823665
Creator: U.S. Food and Drug Administration
Published: 1982-12-30

Substantially Equivalent

Warm & Form, Orthopedic Materials

FDA 510(k) clearance K823665 for ROTATION BOOT, Substantially Equivalent on 1982-12-30. Applicant: Warm & Form, Orthopedic Materials. Device class: 1.

Clearance details

Applicant: Warm & Form, Orthopedic Materials
Product code: Code KNP
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 1982-12-06
Decision date: 1982-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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K810228 — SORBOTHANE1981-02-10
K801743 — PLASTAZOTE SHOE1980-08-07

More clearances from Warm & Form, Orthopedic Materials

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K830244 — TRACTION ACCESSORIES1983-03-09
K830245 — HEAD HALTER1983-03-09
K830243 — ABDUCTION PILLOW1983-03-08
K830246 — CAST SHOE, CAST BOOT1983-02-18
K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL)1982-12-30

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