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510(k) K810271

DIRECT CURRENT BONE GROWTH STIM. AN. PAD by Andover Medical, Inc.

K810271 is an FDA 510(k) premarket notification submitted by Andover Medical, Inc. for the device "DIRECT CURRENT BONE GROWTH STIM. AN. PAD". The FDA issued a decision of Substantially Equivalent on February 19, 1981. Andover Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1981
Date Received
February 2, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Andover Medical, Inc.

  • K905729 — CANMED 451 (February 7, 1991)
  • K903427 — NORTECH MODEL 86901000 ELECTRODE (August 17, 1990)
  • K885171 — MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE (January 12, 1989)
  • K860636 — FASTRACE III, ECG ELECTRODE (May 9, 1986)
  • K854433 — ECG MONITORING/DEFIBRILLATION ELECTRODE (May 8, 1986)
  • K860535 — UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) (April 1, 1986)
  • K860283 — AMI CARDIO-PAD (March 31, 1986)
  • K843412 — FLOW DIRECTED THERMODILUTION CATH W/VEN (November 20, 1984)
  • K843410 — FLOW-DIRECTED PEDIATRIC THERMODIL- CATH (November 20, 1984)
  • K843409 — FLOW-DIRECTED THERMODILUTION CATH (October 18, 1984)

FDA data resources