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510(k) K932507

QUICK-CAST IMMOBILIZER by Landec Corp. — Product Code LGF

K932507 is an FDA 510(k) premarket notification submitted by Landec Corp. for the device "QUICK-CAST IMMOBILIZER". The FDA issued a decision of Substantially Equivalent on February 23, 1994. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1994
Date Received
May 25, 1993
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 for product code LGF

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  • K973420 — CLINITEX CAST PADDING (December 9, 1997)
  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)
  • K955320 — PROTEC COTTON PADDING BANDAGE (January 26, 1996)
  • 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)
  • K874880 — COLORED CASTING TAPE CARAGLAS(TM GREEN (December 30, 1987)

FDA data resources