OP-D-OP II

Accessory, Surgical Apparel

OP-D-OP VISOR SHIELDS, INC.

The following data is part of a premarket notification filed by Op-d-op Visor Shields, Inc. with the FDA for Op-d-op Ii.

Pre-market Notification Details

Device IDK945098
510k NumberK945098
Device Name:OP-D-OP II
ClassificationAccessory, Surgical Apparel
Applicant OP-D-OP VISOR SHIELDS, INC. 8559 WASHINGTON BLVD. Roseville,  CA  95678
ContactTim Landis
CorrespondentTim Landis
OP-D-OP VISOR SHIELDS, INC. 8559 WASHINGTON BLVD. Roseville,  CA  95678
Product CodeLYU  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-18
Decision Date1995-02-28

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