DRAIN-R-DRAPE(EYE— 510(k) K831340

Substantially Equivalent

Sur-Tech, Inc.

FDA 510(k) clearance K831340 for DRAIN-R-DRAPE(EYE, Substantially Equivalent on 1983-06-08. Applicant: Sur-Tech, Inc.. Device class: 2.

Clearance details

Applicant: Sur-Tech, Inc.
Product code: Code HMT
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1983-04-25
Decision date: 1983-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HMT

K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE1995-02-14
K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY1991-02-06
K872620 — SOLOS EYESITE DRAPES1987-07-31
K871706 — OPTHA PREP1987-05-18
K854613 — SURGICAL DRAPES, OPHTHALMIN1986-02-13

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