IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK

Sponge, Ophthalmic

M-PACT WORLDWIDE MANAGEMENT CORP.

The following data is part of a premarket notification filed by M-pact Worldwide Management Corp. with the FDA for Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80cc, Ivalon Eye Drain, 400cc, Ivalon Eye Wick.

Pre-market Notification Details

Device IDK971832
510k NumberK971832
Device Name:IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
ClassificationSponge, Ophthalmic
Applicant M-PACT WORLDWIDE MANAGEMENT CORP. 1040 O.C.L. PKWY. INTECH BUSINESS PK. Eudora,  KS  66025
ContactBarry Hale
CorrespondentBarry Hale
M-PACT WORLDWIDE MANAGEMENT CORP. 1040 O.C.L. PKWY. INTECH BUSINESS PK. Eudora,  KS  66025
Product CodeHOZ  
CFR Regulation Number886.4790 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-19
Decision Date1997-07-31
Summary:summary

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