SURGICAL CAP CALOT— 510(k) K851558

Substantially Equivalent

Roseburg SA

FDA 510(k) clearance K851558 for SURGICAL CAP CALOT, Substantially Equivalent on 1985-04-30. Applicant: Roseburg SA. Device class: 1.

Clearance details

Applicant: Roseburg SA
Product code: Code FYF
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1985-04-16
Decision date: 1985-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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 Roseburg SA

K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE1994-09-01
K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES1989-03-09
K885275 — ASSENAT-BLESCHET SUNGLASSES1989-01-24
K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES1988-08-26
K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY1987-12-07

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