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510(k) K872092

OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 by Military Engineering, Inc. — Product Code KDG

K872092 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5". The FDA issued a decision of Substantially Equivalent on June 23, 1987. The device falls under product code KDG (Chisel (Osteotome)), a Class I device regulated under 21 CFR 878.4820. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1987
Date Received
June 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel (Osteotome)
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Military Engineering, Inc.

  • K874335 — EXPLORER-DENTAL PROBER (December 29, 1987)
  • K873715 — BONE PIN CUTTER 18 (October 28, 1987)
  • K872842 — PIN, HIP, KNOWLES (August 7, 1987)
  • K872091 — CURRETTES, ALVEOLAR (MOLT AND MILLER) (July 31, 1987)
  • K871834 — DRILL, HAND, BONE, SMEDBERG (July 31, 1987)
  • K872738 — CORTICAL BONE SCREWS (July 30, 1987)
  • K872609 — CURETTE SET, ANTRUM, COAKLEY (July 15, 1987)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K870590 — CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY (April 16, 1987)
  • K871195 — MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. (April 6, 1987)

Other clearances for product code KDG

  • K952678 — STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (July 10, 1995)
  • K952200 — OMNI-JUG (June 29, 1995)
  • K894785 — SURGICAL CHISEL/OSTEOTOME (August 18, 1989)
  • K891471 — SIL-MED WASTE FLUID DUMP BAG (August 15, 1989)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K842824 — CHERMEL BONE CHISELS (August 2, 1984)
  • K772374 — SILVER OSTEOTOME (March 9, 1978)
  • K772376 — NEIVERT OSTEOTOME (March 9, 1978)
  • K772373 — ANDERSON-NEIVERT OSTEOTOME (March 9, 1978)
  • K780135 — CEMENT EXTRACTION INSTRUMENT SET (January 31, 1978)

FDA data resources