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510(k) K812904

STERILE ORTHOPEDIC STOCKINETTE by Alba Health Care — Product Code LGF

K812904 is an FDA 510(k) premarket notification submitted by Alba Health Care for the device "STERILE ORTHOPEDIC STOCKINETTE". The FDA issued a decision of Substantially Equivalent on January 18, 1982. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Alba Health Care has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1982
Date Received
October 19, 1981
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 Alba Health Care

  • K864689 — ALBA HEALTH CARE IODOFORM PACKING STRIP (January 20, 1987)
  • K861154 — ALBA HEALTH CARE PLAIN PACKING STRIP (April 15, 1986)
  • K851918 — INFANT PHOTOTHERAPY MASK (June 7, 1985)
  • K850881 — ALBA DRY BURN PAD (April 17, 1985)
  • K850904 — ALBA DRY BURN DRESSING (April 17, 1985)
  • K850241 — ALBA HEALTH CARE NON-ADHERING DRESSING (March 12, 1985)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)

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