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510(k) K971375

GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE by Wilson Greatbatch Technologies, Inc. — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1997
Date Received
April 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nasopharyngoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Wilson Greatbatch Technologies, Inc.

  • K971374 — GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE (May 13, 1998)
  • K971377 — GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (April 30, 1998)
  • K972280 — GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES (December 11, 1997)
  • K971781 — GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES (November 21, 1997)
  • K970619 — GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE (November 19, 1997)
  • K954649 — WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP (December 22, 1995)
  • K950063 — WGL ENDOSCOPIC GRASPER* (January 27, 1995)
  • K942168 — WGL ENDOSCOPIC GRASPER (December 13, 1994)

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