EYE DRAPE

Drape, Patient, Ophthalmic

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Eye Drape.

Pre-market Notification Details

• Device ID: K830822
• 510k Number: K830822
• Device Name: EYE DRAPE
• Classification: Drape, Patient, Ophthalmic
• Applicant: COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb
• Product Code: HMT
• CFR Regulation Number: 878.4370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-03-15
• Decision Date: 1983-04-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10080196498819	K830822	000
10380651031200	K830822	000
10380651032207	K830822	000
10380651033204	K830822	000
10380651034010	K830822	000
10380651038209	K830822	000
10380651040202	K830822	000
10380651041209	K830822	000
10380651042206	K830822	000
10380651043203	K830822	000
10380651030203	K830822	000
10380651029207	K830822	000
10380650026207	K830822	000
10380650029208	K830822	000
10380651020204	K830822	000
10380651021201	K830822	000
10380651022208	K830822	000
10380651023205	K830822	000
10380651026206	K830822	000
10380651027203	K830822	000
10380651028200	K830822	000
10380651044200	K830822	000
10380651045207	K830822	000
10380651050201	K830822	000
10380651173207	K830822	000
10380651525204	K830822	000
10380651530208	K830822	000
10380651531205	K830822	000
10380651532202	K830822	000
10380651533209	K830822	000
10380651543208	K830822	000
10380651544205	K830822	000
10380651546209	K830822	000
10380651172200	K830822	000
10380651171203	K830822	000
10380651055206	K830822	000
10380651056203	K830822	000
10380651062204	K830822	000
10380651063201	K830822	000
10380651120201	K830822	000
10380651126203	K830822	000
10380651129204	K830822	000
10380651130200	K830822	000
10380651170206	K830822	000
10380657407450	K830822	000