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510(k) K875223

DANNINGER ORTHOPAEDIC AWL by Danninger Medical Technology, Inc. — Product Code HWJ

K875223 is an FDA 510(k) premarket notification submitted by Danninger Medical Technology, Inc. for the device "DANNINGER ORTHOPAEDIC AWL". The FDA issued a decision of Substantially Equivalent on February 17, 1988. The device falls under product code HWJ (Awl), a Class I device regulated under 21 CFR 888.4540. Danninger Medical Technology, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1988
Date Received
December 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Awl
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Danninger Medical Technology, Inc.

  • K931128 — BASIC SHOULDER CPM (May 6, 1994)
  • K933394 — DANNIFLEX CPM 600 (March 11, 1994)
  • K913026 — TTU-100THERMAL THERAPY UNIT (December 13, 1991)
  • K862730 — DANNIFLEX 400SL (July 24, 1986)
  • K844033 — MOBILIMB HAND UNIT (November 27, 1984)

Other clearances for product code HWJ

  • K895587 — CROSS MEDICAL PRODUCT PEDICLE AWL (January 4, 1990)
  • K880045 — ACROMED AWL/PUNCH, DEPTH GAUGE (February 17, 1988)
  • K870779 — ACROMED WALLIE-HEINIG TROCHAR (March 9, 1987)

FDA data resources