Cleared Traditional

EYE DRAPE

K830822 · CooperVision, Inc. · General Hospital
Apr 1983
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K830822 is an FDA 510(k) clearance for the EYE DRAPE, a Drape, Patient, Ophthalmic (Class II — Special Controls, product code HMT), submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on April 6, 1983, 22 days after receiving the submission on March 15, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K830822 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1983
Decision Date April 06, 1983
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code HMT — Drape, Patient, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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