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510(k) K841509

REPLACE-A-TIP ADJUSTABLE HIGH TEMP. by Suncoast Medical Manufacturers, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1984
Date Received
April 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Suncoast Medical Manufacturers, Inc.

  • K841603 — ADJUST-A-TEMP MICRO (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)
  • 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)
  • K840375 — SURG-A-STAT LOOP TIP 15 (July 23, 1984)
  • K841588 — SUN-LITE WHITE SPOT (May 22, 1984)

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