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510(k) K920271

WEINSTEIN CORNEAL MIRCOAESTHESIOMETER by Connecticut Bioinstruments, Inc. — Product Code HJC

K920271 is an FDA 510(k) premarket notification submitted by Connecticut Bioinstruments, Inc. for the device "WEINSTEIN CORNEAL MIRCOAESTHESIOMETER". The FDA issued a decision of Substantially Equivalent on April 21, 1992. The device falls under product code HJC (Esthesiometer, Ocular), a Class I device regulated under 21 CFR 886.1040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1992
Date Received
January 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esthesiometer, Ocular
Device Class
Class I
Regulation Number
886.1040
Review Panel
OP
Submission Type

Other clearances for product code HJC

  • K851557 — ANESTHESIOMETER (May 30, 1985)

FDA data resources