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510(k) K944311

ACRA-CUT by Acra Cut, Inc. — Product Code HBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1994
Date Received
September 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Scalp
Device Class
Class II
Regulation Number
882.4150
Review Panel
NE
Submission Type

Other clearances by Acra Cut, Inc.

  • K032970 — ACRA-CUT XPRESS 120 (December 8, 2003)
  • K911812 — ACRA-CUT WIRE PASS DRILL (September 10, 1991)
  • K911819 — ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED (September 10, 1991)
  • K910226 — DURAL DISSECTORS (February 12, 1991)
  • K910225 — BONE PAD REMOVER (February 12, 1991)
  • K892866 — AUTOMATIC CRANIAL DRILL (PERFORATOR) (June 15, 1989)
  • K833266 — ACRA-CUT (December 29, 1983)

Other clearances for product code HBO

  • K050044 — MEDTRONIC CLIP GUN KIT (February 7, 2005)
  • K033660 — STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (January 7, 2004)
  • K012219 — SCALPFIX CLIP SYSTEM (July 31, 2001)
  • K905433 — CODMAN DISPOSABLE SCALP CLIP APPLIER (February 21, 1991)
  • K896723 — CLIP GUN WITH RANEY TYPE SCALP CLIPS (March 23, 1990)
  • K894778 — CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER (December 6, 1989)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K883963 — RANEY AND LEROY-RANEY SCALP CLIP (October 7, 1988)
  • K881265 — RANEY CLIPS (May 31, 1988)