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510(k) K903946

COOL CAST(R) by Hawthorne Products, Inc. — Product Code LGF

K903946 is an FDA 510(k) premarket notification submitted by Hawthorne Products, Inc. for the device "COOL CAST(R)". The FDA issued a decision of Substantially Equivalent on December 31, 1990. 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 31, 1990
Date Received
August 27, 1990
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

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  • 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)
  • 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