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510(k) K841588

SUN-LITE WHITE SPOT by Suncoast Medical Manufacturers, Inc. — Product Code KYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1984
Date Received
April 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Examination, Medical, Battery Powered
Device Class
Class I
Regulation Number
880.6350
Review Panel
HO
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)
  • K841459 — REPLACE-A-TIP ADJUST. LOW TEMP.- (December 7, 1984)
  • K841604 — ADJUST-A-TEMP HIGH TEMPERATURE (December 7, 1984)
  • K841591 — PYRO-TIP (October 31, 1984)
  • K840376 — SURG-A STAT LOOP TIP (October 26, 1984)
  • K840387 — SURG-A-STAT LOOP TIP 2 (July 23, 1984)
  • K840370 — SURG-A-STAT VASECTOMY TIP (July 23, 1984)
  • K840377 — SURG-A-STAT CARDIOVASCULAR TIP (July 23, 1984)
  • K840375 — SURG-A-STAT LOOP TIP 15 (July 23, 1984)

Other clearances for product code KYT

  • K920782 — OLYMPIC TRANS-LITE (March 27, 1992)
  • K841589 — C-LITE (May 22, 1984)
  • K791001 — PENLIGHT/SWAB HOLDER (June 22, 1979)
  • K781228 — PENLIGHTS (September 7, 1978)
  • K760972 — TYCOS DIAGNOSTIC PENLIGHT (January 26, 1977)