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510(k) K874845

MALIS SURGICAL LOUPES by Valley Forge Scientific Corp. — Product Code HJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1987
Date Received
November 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Loupe, Binocular, Low Power
Device Class
Class I
Regulation Number
886.5120
Review Panel
OP
Submission Type

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  • K971986 — VALLEY FORGE BIPOLAR LOOP (August 26, 1997)
  • K964143 — MINI-SYMM BIPOLAR COAGULATOR (January 9, 1997)
  • K955764 — VALLEY FORGE BIPLOAR LOOP (March 1, 1996)
  • K955346 — VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM (December 8, 1995)

Other clearances for product code HJH

  • K863983 — EXETER OPERATING LOUPE (November 10, 1986)
  • K830878 — BINOCULAR LOUPE (April 6, 1983)