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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sponge, ophthalmic
510(k) Number K003842
Device Name PRESCOTT'S SURGICAL SPEAR
Applicant
PRESCOTT'S, INC.
P.O. BOX 609
MONUMENT,  CO  80132 -0609
Applicant Contact PAUL REDNER
Correspondent
PRESCOTT'S, INC.
P.O. BOX 609
MONUMENT,  CO  80132 -0609
Correspondent Contact PAUL REDNER
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received12/12/2000
Decision Date 04/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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