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510(k) K881515

TEAR VOLUME TESTS by Visionex, Inc. — Product Code KYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1988
Date Received
April 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Schirmer
Device Class
Class I
Regulation Number
886.1800
Review Panel
OP
Submission Type

Other clearances by Visionex, Inc.

  • K902296 — TRABECULO-SUPRACHOROIDAL SHUNT (March 14, 1991)

Other clearances for product code KYD

  • K911734 — TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM (November 7, 1991)
  • K832181 — SNO STRIPS STERILE TEARFLOW TEST STRIP (August 12, 1983)