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510(k) K861074

AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200 by Martin Medical — Product Code LGF

K861074 is an FDA 510(k) premarket notification submitted by Martin Medical for the device "AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200". The FDA issued a decision of Substantially Equivalent on March 28, 1986. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Martin Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1986
Date Received
March 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 Martin Medical

  • K873723 — PLASTER VACUUM, 230V MODEL NO. 4183-161 (December 10, 1987)
  • K873721 — PLASTER VACUUM, 115V MODEL NO. 4183-160 (December 7, 1987)
  • K873718 — CHILD WALKING HEEL PRODUCT NO. 4183-132 (October 2, 1987)
  • K873717 — CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 (October 2, 1987)
  • K873716 — ADULT WALKING HEEL PRODUCT NO. 4183-130 (October 2, 1987)
  • K873719 — CAST CUTTER, 115V MODEL NO. 4183-106 (October 2, 1987)
  • K873722 — PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 (October 2, 1987)
  • K873720 — CAST CUTTER, 230V MODEL NO. 4183-107 (October 2, 1987)
  • K863273 — MARTIN MEDICAL PRO-SCOPE ANOSCOPE (November 4, 1986)
  • K863275 — MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM (September 2, 1986)

Other clearances for product code LGF

  • K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (March 10, 2005)
  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)
  • K973420 — CLINITEX CAST PADDING (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