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510(k) K833866

ACE/KYLE SELF TAPPING CANNULATED TITA by Buckman Co., Inc. — Product Code JPW

K833866 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACE/KYLE SELF TAPPING CANNULATED TITA". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code JPW (Pump, Nebulizer, Electrically Powered), a Class I device regulated under 21 CFR 874.5220. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
November 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Nebulizer, Electrically Powered
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by Buckman Co., Inc.

  • K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM (June 25, 1998)
  • K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM (June 8, 1998)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM (January 16, 1997)
  • K960451 — WEBB-MORLEY SPINE SYSTEM (April 18, 1996)
  • K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS (January 25, 1996)
  • K945756 — IMAGN(TM) 2000 SYSTEM (December 19, 1995)
  • K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (October 19, 1995)
  • K951117 — LIHTAN 532 LASER (October 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)

FDA data resources