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510(k) K780433

FIBER OPTIC ADJUSTABLE HEADLIGHT by Cameron-Miller, Inc. — Product Code FCT

K780433 is an FDA 510(k) premarket notification submitted by Cameron-Miller, Inc. for the device "FIBER OPTIC ADJUSTABLE HEADLIGHT". The FDA issued a decision of Substantially Equivalent on June 13, 1978. The device falls under product code FCT (Headlight, Fiberoptic Focusing), a Class II device regulated under 21 CFR 886.4335. Cameron-Miller, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1978
Date Received
March 17, 1978
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

Other clearances by Cameron-Miller, Inc.

  • K944775 — ELECTROSURGICAL UNIT MODEL 26-0335 (October 11, 1994)
  • K931541 — MODEL 26-0375, ELECTROSURGICAL GENERATOR (June 1, 1994)
  • K931437 — MODEL 80-1983, ELECTROSURGICAL GENERATOR (May 27, 1994)
  • K935490 — ELECTROSURGICAL DEVICE, MODEL 26-2500 (April 1, 1994)
  • K854109 — ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345 (January 24, 1986)
  • K853972 — CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR (January 24, 1986)
  • K833449 — HAND CONTROLLED PENCIL OR SWITCH HAND (November 29, 1983)
  • K822092 — CAMERON-MILLER #40-1516 (September 21, 1982)
  • K812702 — TECHNICATOR (November 5, 1981)
  • K791415 — MODEL 80-1765 ELECTROSURGICAL UNIT (October 11, 1979)

Other clearances for product code FCT

  • K960767 — LIGHT COMMANDER (August 26, 1996)
  • K924198 — MODIFIED SITE FIBER OPTIC MODULE (November 23, 1992)
  • K883480 — MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE (August 24, 1988)
  • K802769 — FIBER OPTIC HEADLIGHT #60-0765 (December 11, 1980)
  • K802770 — FIBER OPTIC HEADLIGHT #60-0766766 (December 11, 1980)

FDA data resources