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510(k) K945098

OP-D-OP II by Op-D-Op Visor Shields, Inc. — Product Code LYU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1995
Date Received
October 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Surgical Apparel
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

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