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510(k) K971134

VISTA EYESHOWER by John Branch — Product Code LXQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 4, 1997
Date Received: March 28, 1997
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cup, Eye
Device Class: Class U
Regulation Number
Review Panel: OP
Submission Type