P.S.M. JUSTA KAP— 510(k) K761071

Substantially Equivalent

The Owenby Co.

FDA 510(k) clearance K761071 for P.S.M. JUSTA KAP, Substantially Equivalent on 1976-12-30. Applicant: The Owenby Co.. Device class: 1.

Clearance details

Applicant: The Owenby Co.
Product code: Code FYF
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1976-11-16
Decision date: 1976-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FYF

K972227 — SHOE COVER1997-09-09
K955833 — NIOMED SURGICAL CAPS1996-03-15
K954556 — SURGICAL CAP1996-03-12
K954454 — NIOMED SURGICAL HOOD1996-01-23
K954455 — NIOMED BOUFFANT CAPS1996-01-23

More clearances from The Owenby Co.

K801628 — RESTRAINT, PROTECTIVE1980-08-07
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

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