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510(k) K840371

FLEXIBLE ILLUMINATOR 5 by Suncoast Medical Manufacturers, Inc. — Product Code FTF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1984
Date Received
January 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Non-Remote
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Suncoast Medical Manufacturers, Inc.

  • K841603 — ADJUST-A-TEMP MICRO (December 7, 1984)
  • K841509 — REPLACE-A-TIP ADJUSTABLE HIGH TEMP. (December 7, 1984)
  • K841604 — ADJUST-A-TEMP HIGH TEMPERATURE (December 7, 1984)
  • K841459 — REPLACE-A-TIP ADJUST. LOW TEMP.- (December 7, 1984)
  • K841591 — PYRO-TIP (October 31, 1984)
  • K840376 — SURG-A STAT LOOP TIP (October 26, 1984)
  • K840375 — SURG-A-STAT LOOP TIP 15 (July 23, 1984)
  • K840377 — SURG-A-STAT CARDIOVASCULAR TIP (July 23, 1984)
  • K840387 — SURG-A-STAT LOOP TIP 2 (July 23, 1984)
  • K840370 — SURG-A-STAT VASECTOMY TIP (July 23, 1984)

Other clearances for product code FTF

  • K041621 — LITEPORT LP100 SURGICAL ILLUMINATOR (September 13, 2004)
  • K840373 — FLEXIBLE ILLUMINATOR 10 (April 24, 1984)
  • K840372 — FLEXIBLE ILLUMINATOR 15 (April 24, 1984)