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510(k) K853972

CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR by Cameron-Miller, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
September 26, 1985
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 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)
  • 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)
  • K781353 — PAPILLOTOME CUTTING SNARE (October 10, 1978)

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