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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spud, Ophthalmic
510(k) Number K931449
Device Name MSP OPHTHALMIC (EYE SPUD)
Applicant
Medical Sterile Products, Inc.
P.O. Box 338
Bo. Ensenada Rd. 413, Km 0.2
Rincon,  PR  00677
Applicant Contact DAVID WISHINSKY
Correspondent
Medical Sterile Products, Inc.
P.O. Box 338
Bo. Ensenada Rd. 413, Km 0.2
Rincon,  PR  00677
Correspondent Contact DAVID WISHINSKY
Regulation Number886.4350
Classification Product Code
HNA  
Date Received03/23/1993
Decision Date 08/31/1993
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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