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510(k) K911521

ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP by Andronic Devices, Ltd. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1991
Date Received
April 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Andronic Devices, Ltd.

  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K934926 — INSITE MODEL 20 & MODEL 15 INSUFFLATORS (May 26, 1994)
  • K934928 — INSITE FILTER & TUBING SET (May 26, 1994)
  • K935381 — KAPS POSITIONING ARM (April 15, 1994)
  • K934124 — AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM (April 13, 1994)
  • K936308 — ENDEX ENDOSCOPIC POSITIONING SYSTEM (March 31, 1994)
  • K932253 — ARTHROBOT BI-FOLD DRAPE (February 3, 1994)
  • K922626 — ADEPT INSTRUMENT POSITIONING ACCESSORY (October 19, 1992)
  • K922625 — ADEPT ENDOSCOPIC POSITIONER (October 19, 1992)
  • K911520 — ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE (August 2, 1991)

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