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510(k) K904961

ARTIFICIAL SCLERAL SHELL by Midwest Eye Laboratories, Inc. — Product Code HQT

K904961 is an FDA 510(k) premarket notification submitted by Midwest Eye Laboratories, Inc. for the device "ARTIFICIAL SCLERAL SHELL". The FDA issued a decision of Substantially Equivalent on August 30, 1991. The device falls under product code HQT (Shell, Scleral), a Class II device regulated under 21 CFR 886.3800. Midwest Eye Laboratories, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1991
Date Received
November 5, 1990
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 Midwest Eye Laboratories, Inc.

  • K904962 — EYE ARTIFICIAL CUSTOM (August 30, 1991)

Other clearances for product code HQT

  • K970320 — SCLERAL SHELL (July 7, 1997)
  • K970327 — SCLERAL SHELL (July 7, 1997)
  • K855105 — SIMMONS SHELL (March 31, 1986)

FDA data resources