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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 K971832
Device Name IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
Applicant
M-Pact Worldwide Management Corp.
1040 O.C.L. Pkwy.
Intech Business Pk.
Eudora,  KS  66025
Applicant Contact BARRY HALE
Correspondent
M-Pact Worldwide Management Corp.
1040 O.C.L. Pkwy.
Intech Business Pk.
Eudora,  KS  66025
Correspondent Contact BARRY HALE
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received05/19/1997
Decision Date 07/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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