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510(k) K951184

OTI MODEL 78-60 by Oti Medical, LLC — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1995
Date Received
March 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Oti Medical, LLC

  • K951437 — OTI MODEL TLS-60 (April 11, 1995)

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