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510(k) K884740

EURO-MED LIGHT TOUCH BIOPSY PUNCH by Buckman Co., Inc. — Product Code EME

K884740 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "EURO-MED LIGHT TOUCH BIOPSY PUNCH". The FDA issued a decision of Substantially Equivalent on March 6, 1989. The device falls under product code EME (Punch, Biopsy, Surgical), a Class I device regulated under 21 CFR 872.4565. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1989
Date Received
November 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Punch, Biopsy, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
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)

Other clearances for product code EME

  • K933670 — BIOPSY PUNCH, SURGICAL (January 7, 1994)
  • K911285 — PULPDENT POLYAMIDE DENTIN LINER (October 9, 1991)

FDA data resources