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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Weights, Eyelid, External
510(k) Number K021750
Device Name LID CHAIN EYELID WEIGHTS
Applicant
JEDMED INSTRUMENT CO.
5416 JEDMED CT.
ST. LOUIS,  MO  63129 -2221
Applicant Contact CRAIG R PARKS
Correspondent
JEDMED INSTRUMENT CO.
5416 JEDMED CT.
ST. LOUIS,  MO  63129 -2221
Correspondent Contact CRAIG R PARKS
Regulation Number886.5700
Classification Product Code
MML  
Date Received05/28/2002
Decision Date 01/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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