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510(k) K802769

FIBER OPTIC HEADLIGHT #60-0765 by Aspen Laboratories, Inc. — Product Code FCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
November 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headlight, Fiberoptic Focusing
Device Class
Class II
Regulation Number
886.4335
Review Panel
OP
Submission Type

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Other clearances for product code FCT

  • K960767 — LIGHT COMMANDER (August 26, 1996)
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  • K883480 — MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE (August 24, 1988)
  • K802770 — FIBER OPTIC HEADLIGHT #60-0766766 (December 11, 1980)
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