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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plug, Scleral
510(k) Number K871604
Device Name MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
Applicant
Advanced Surgical Products, Inc.
524 Chele Dr. St.
Charles,  MO  63303
Applicant Contact TODD HESSEL
Correspondent
Advanced Surgical Products, Inc.
524 Chele Dr. St.
Charles,  MO  63303
Correspondent Contact TODD HESSEL
Regulation Number886.4155
Classification Product Code
LXP  
Date Received04/24/1987
Decision Date 06/12/1987
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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