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510(k) K970320

SCLERAL SHELL by Xavier A. Guerra, Ocularist, Inc. — Product Code HQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1997
Date Received
January 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shell, Scleral
Device Class
Class II
Regulation Number
886.3800
Review Panel
OP
Submission Type

Other clearances by Xavier A. Guerra, Ocularist, Inc.

  • K970319 — OCULAR CONFORMER (July 7, 1997)

Other clearances for product code HQT

  • K970327 — SCLERAL SHELL (July 7, 1997)
  • K904961 — ARTIFICIAL SCLERAL SHELL (August 30, 1991)
  • K855105 — SIMMONS SHELL (March 31, 1986)