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510(k) K864092

OEC DESIGN ORTHOPEDIC CAST HEEL by Military Engineering, Inc. — Product Code LGF

K864092 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "OEC DESIGN ORTHOPEDIC CAST HEEL". The FDA issued a decision of Substantially Equivalent on December 16, 1986. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1986
Date Received
October 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Cast
Device Class
Class I
Regulation Number
888.5940
Review Panel
OR
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 LGF

  • K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (March 10, 2005)
  • K973420 — CLINITEX CAST PADDING (December 9, 1997)
  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)
  • K955320 — PROTEC COTTON PADDING BANDAGE (January 26, 1996)
  • K932507 — QUICK-CAST IMMOBILIZER (February 23, 1994)
  • K931672 — CARAPACE STERILE CAST PADDING (December 15, 1993)
  • K910274 — ARTIFLEX(TM) (March 5, 1991)
  • K903946 — COOL CAST(R) (December 31, 1990)
  • K896634 — CARAGLAS XTRA SYNTHETIC CASTING TAPE (June 14, 1990)
  • K883294 — SYNTHETIC CAST TAPE (August 30, 1988)

FDA data resources