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510(k) K840428

SUN-LITE PEN LIGHT by Suncoast Medical Manufacturers, Inc.

K840428 is an FDA 510(k) premarket notification submitted by Suncoast Medical Manufacturers, Inc. for the device "SUN-LITE PEN LIGHT". The FDA issued a decision of Substantially Equivalent on May 9, 1984. Suncoast Medical Manufacturers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
January 31, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Suncoast Medical Manufacturers, Inc.

  • 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)
  • K841603 — ADJUST-A-TEMP MICRO (December 7, 1984)
  • K841591 — PYRO-TIP (October 31, 1984)
  • K840376 — SURG-A STAT LOOP TIP (October 26, 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)
  • K840387 — SURG-A-STAT LOOP TIP 2 (July 23, 1984)

FDA data resources