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510(k) K871195

MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. by Military Engineering, Inc. — Product Code HXL

K871195 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.". The FDA issued a decision of Substantially Equivalent on April 6, 1987. The device falls under product code HXL (Mallet), a Class I device regulated under 21 CFR 878.4800. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1987
Date Received
March 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mallet
Device Class
Class I
Regulation Number
878.4800
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)
  • K872092 — OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (June 23, 1987)
  • K870590 — CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY (April 16, 1987)

Other clearances for product code HXL

  • K882349 — MALLET, SURGICAL (June 23, 1988)
  • K872209 — ARTHROPLASTY MALLET (June 23, 1987)

FDA data resources