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510(k) K924606

BREMER IMAGING TONGS-MRI MODEL by Bremer Medical, Inc. — Product Code HAX

K924606 is an FDA 510(k) premarket notification submitted by Bremer Medical, Inc. for the device "BREMER IMAGING TONGS-MRI MODEL". The FDA issued a decision of Substantially Equivalent on September 9, 1993. The device falls under product code HAX (Tong, Skull For Traction), a Class II device regulated under 21 CFR 882.5960. Bremer Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1993
Date Received
September 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tong, Skull For Traction
Device Class
Class II
Regulation Number
882.5960
Review Panel
NE
Submission Type

Other clearances by Bremer Medical, Inc.

  • K915800 — BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN (March 16, 1992)

Other clearances for product code HAX

  • K090733 — PMT HALO SYSTEM (July 28, 2009)
  • K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D (May 25, 2007)
  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K023959 — JEROME GLASS RING (February 21, 2003)
  • K003662 — SPINE WORKS COLLAR (July 9, 2001)
  • K980689 — FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (February 18, 1999)
  • K930021 — J TONGS (December 6, 1995)
  • K954069 — ACE CERVICAL TRACTION HALOZS, TONGS & PINS (October 12, 1995)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
  • K873693 — LEVTECH COMPOSITE TRACTION TONGS (February 5, 1988)

FDA data resources