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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Lachrymal
510(k) Number K833671
Device Name STERILE OIL AND GUIDEWIRE
Applicant
CooperVision, Inc.
Permalens House
1 Botley Rd., Hedge End
Southampton,  GB S033HB
Correspondent
CooperVision, Inc.
Permalens House
1 Botley Rd., Hedge End
Southampton,  GB S033HB
Regulation Number886.4350
Classification Product Code
HNL  
Date Received10/18/1983
Decision Date 01/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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