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510(k) K874880

COLORED CASTING TAPE CARAGLAS(TM GREEN by Synthetic Mfg., Inc. — Product Code LGF

K874880 is an FDA 510(k) premarket notification submitted by Synthetic Mfg., Inc. for the device "COLORED CASTING TAPE CARAGLAS(TM GREEN". The FDA issued a decision of Substantially Equivalent on December 30, 1987. 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
December 30, 1987
Date Received
December 1, 1987
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)
  • 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