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510(k) K050364

MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM by Valley Forge Scientific Corp. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2005
Date Received
February 14, 2005
Clearance Type
Special
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 Valley Forge Scientific Corp.

  • K042604 — VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL (October 22, 2004)
  • K032601 — STRYKER INTERVENTIONAL PAIN RF GENERATOR (April 1, 2004)
  • K033499 — MALIS IRRIGATION MODULE 1000 (November 28, 2003)
  • K982229 — BI-DENT (August 13, 1998)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (December 19, 1997)
  • K971986 — VALLEY FORGE BIPOLAR LOOP (August 26, 1997)
  • K964143 — MINI-SYMM BIPOLAR COAGULATOR (January 9, 1997)
  • K955764 — VALLEY FORGE BIPLOAR LOOP (March 1, 1996)
  • K955346 — VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM (December 8, 1995)
  • K951985 — PRECISION BIPOLAR COAGULATOR (May 23, 1995)

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