ROSEBUD DISSECTORS

Gauze/sponge, Internal

ORMED MFG., INC.

The following data is part of a premarket notification filed by Ormed Mfg., Inc. with the FDA for Rosebud Dissectors.

Pre-market Notification Details

Device IDK880852
510k NumberK880852
Device Name:ROSEBUD DISSECTORS
ClassificationGauze/sponge, Internal
Applicant ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo,  NY  14207
ContactAnn M Johnson
CorrespondentAnn M Johnson
ORMED MFG., INC. 175 GREAT ARROW AVE. Buffalo,  NY  14207
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-01
Decision Date1988-03-17

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