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510(k) K911353

EMC MODEL NO. STATOME 900 by Emc Industries — Product Code HAM

K911353 is an FDA 510(k) premarket notification submitted by Emc Industries for the device "EMC MODEL NO. STATOME 900". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Emc Industries has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
March 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Emc Industries

  • K952231 — EMC MODEL STATOME 200 (November 21, 1995)
  • K941721 — EMC MODEL NO. 322870 ENDOSTAT (July 6, 1994)

Other clearances for product code HAM

  • K153472 — Quiver Laparoscopic Extendable (June 23, 2016)
  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K913300 — LAPAROSTAT(TM) (April 2, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K894663 — BEAMER ONE (September 15, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)

FDA data resources