RESTRAINT, PROTECTIVE— 510(k) K801628

Substantially Equivalent

The Owenby Co.

FDA 510(k) clearance K801628 for RESTRAINT, PROTECTIVE, Substantially Equivalent on 1980-08-07. Applicant: The Owenby Co.. Device class: 1.

Clearance details

Applicant: The Owenby Co.
Product code: Code IQK
Device class: Class 1
Regulation: 21 CFR 890.3490
Advisory panel: Physical Medicine
Date received: 1980-07-15
Decision date: 1980-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code IQK

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K926291 — SCHUL-TEC IMMOBILIZER1993-03-30
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K896042 — MEDICAL DISPOSABLE BEDDING1990-01-10
K882264 — BATTLE CREEK PILLOW1988-08-09

More clearances from The Owenby Co.

K801532 — STOCKINETTE, STERILE TWO PLY W/PULL TABS1980-07-28
K801626 — ARM SLING1980-07-28
K801627 — COVER, LIMB1980-07-28
K801531 — ARM SLING1980-07-21
K790210 — STOCKINETTE, TUBULAR UNBLEACHED1979-02-27

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