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510(k) K861749

3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE by Keeler Instruments, Inc. — Product Code FSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1986
Date Received
May 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Loupe, Diagnostic/Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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Other clearances for product code FSP

  • K895248 — IMS5000 ILLUMINATED LOUPES (September 15, 1989)
  • K891895 — SURGICAL LOUPES (April 12, 1989)
  • K864386 — LUXTEC LOUPES FOR SURGICAL VISION (November 17, 1986)