STERILE SURGICAL DRAPES— 510(k) K821666

Substantially Equivalent

Phoenix Glove Co.

FDA 510(k) clearance K821666 for STERILE SURGICAL DRAPES, Substantially Equivalent on 1982-06-21. Applicant: Phoenix Glove Co.. Device class: 2.

Clearance details

Applicant: Phoenix Glove Co.
Product code: Code FJZ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1982-06-07
Decision date: 1982-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FJZ

K821313 — SURGICAL UTILITY DRAPE1982-06-21
K760995 — DECOLLATING TRAY1977-01-06

More clearances from Phoenix Glove Co.

K830660 — STERILE SURGICAL DRAPES1983-03-17
K821044 — PATIENT PREP KITS/TRAYS-STERILE1982-06-23
K821043 — STERILE PATIENT EXAM. GLOVES1982-05-21
K801846 — ELECTROCARDIOGRAPH ELECTRODE1980-09-09
K781820 — GLOVES, VINYL EXAMINATION1978-12-07

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