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510(k) K861073

AMERICAN ORTHOPAEDIC VACUUM 0295-250 by Martin Medical — Product Code LGF

K861073 is an FDA 510(k) premarket notification submitted by Martin Medical for the device "AMERICAN ORTHOPAEDIC VACUUM 0295-250". The FDA issued a decision of Substantially Equivalent on Mar 28, 1986. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Martin Medical has 13 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 28, 1986
Date Received
Mar 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
510(k) Exempt

Other clearances by Martin Medical

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

Other clearances for product code LGF

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

FDA data resources

Source: FDA 510(k) database entry for K861073. Report a data issue: hello@regdatalab.com.